24-25 September 2026
MTAA RegConnect Summit 2026 Program
8.30am
Registration opens | Coffee cart available
9.00 - 9.25am
Plenary
Welcome to Country
Introduction
Ian is CEO of the Medical Technology Association of Australia, the peak national association representing companies in the medical device industry. Ian’s previous CEO roles have included commercial health organisations and also medical professional associations – the Australian Dental Association (NSW) and the Australian Orthopaedic Association. Ian holds an MBA from Macquarie University and a Bachelor of Economics from the Australian National University, and he is a member of the Australian Institute of Company Directors. Ian is also a non-executive director of Red Nose, formerly known as SIDS & Kids, a well-respected not-for-profit organisation that is dedicated to saving the lives of babies and children.
Jasjit Baveja is Director of Regulatory and Industry Policy at MTAA, where she leads regulatory policy development and industry engagement with the Therapeutic Goods Administration. She brings over a decade of hands-on experience in medical device regulation. A long-standing advocate for women in the medical technology industry, Jasjit has co-led women’s network employee resource groups at both Boston Scientific and Johnson & Johnson, and continues to champion gender diversity and inclusion across the sector through her work at MTAA.
9.25 - 9.35am
Plenary
1
Beyond the Paperwork: A Lived Experience
9.40 - 10.35am
Plenary
IMDRF Priorities: Setting the Global Agenda
Jasjit Baveja is Director of Regulatory and Industry Policy at MTAA, where she leads regulatory policy development and industry engagement with the Therapeutic Goods Administration. She brings over a decade of hands-on experience in medical device regulation. A long-standing advocate for women in the medical technology industry, Jasjit has co-led women’s network employee resource groups at both Boston Scientific and Johnson & Johnson, and continues to champion gender diversity and inclusion across the sector through her work at MTAA.
Tracey leads the Medical Devices and Product Quality Division at the TGA. Her team is responsible for the pre-market assessment and post-market monitoring of medical devices, laboratory testing of therapeutic goods, GMP licencing and inspections, and national therapeutic goods recalls.
Nada Alkhayat is a Policy Officer at the European Commission’s unit for Medical Devices in the Directorate General for Health and Food Safety (DG SANTE). In her team, Nada holds a horizontal role in the implementation of the medical devices regulations, leading the work on international and chairs the Medical Device Coordination Groups on New Technologies, Nomenclature and International Matters. Her special interest areas include medical device software, Artificial intelligence and in vitro diagnostic medical devices. Prior to joining the European Commission, Nada was a Regulations & Industrial Policy Officer at MedTech Europe.
Dr. Kenneth J. Cavanaugh Jr. has been employed at the U.S. Food and Drug Administration Center for Devices and Radiological Health since 2003 and is currently the Associate Director for International Policy and Strategy. In this role, he oversees the international affairs activities for medical devices and represents the Center on the Management Committee of the International Medical Device Regulators Forum (IMDRF), as co-chair of the IMDRF Good Regulatory Review Practices Working Group, and in multiple international consensus standards development committees. Prior to his current role, he spent over 20 years in FDA’s Office of Cardiovascular Devices as a scientific reviewer, supervisor, and Deputy Office Director.
10:40am - 11:05am
Morning tea in the Showcase Arena
11:05am - 12:00pm
Plenary
EU MDR: State of Play
Dr. Bassil Akra is a distinguished leader in medical device and in-vitro diagnostic device regulation, with extensive expertise spanning R&D, manufacturing, testing, conformity assessment, and standards development. As Chief Executive Officer of AKRA TEAM since July 2021, he supports the various stakeholders in developing and executing compliant regulatory, clinical, and quality strategies in the EU, effectively bridging the language between legislators, notified bodies, and industry stakeholders. He also supports the various due diligence activities and court cases which require his independent and impartial subject matter expertise.
Diana Kanecka is Director of International Affairs at MedTech Europe and Co-Chair of the Global Medical Technology Alliance (GMTA). She leads MedTech Europe’s international affairs activities, with a particular focus on advancing regulatory convergence, facilitating global trade and addressing barriers to patient access to medical technologies. Diana brings extensive experience in regulatory affairs, including the EU Medical Devices and in vitro Diagnostic Medical Devices Regulations, as well as international trade policy. Her experience in the medical technology sector and policy work underpins her commitment to fostering policies and international cooperation that support timely and sustainable access to innovative medical technologies.
Nada Alkhayat is a Policy Officer at the European Commission’s unit for Medical Devices in the Directorate General for Health and Food Safety (DG SANTE). In her team, Nada holds a horizontal role in the implementation of the medical devices regulations, leading the work on international and chairs the Medical Device Coordination Groups on New Technologies, Nomenclature and International Matters. Her special interest areas include medical device software, Artificial intelligence and in vitro diagnostic medical devices. Prior to joining the European Commission, Nada was a Regulations & Industrial Policy Officer at MedTech Europe.
- Founding Member of the European Association of Authorized Representatives (EAAR); long-standing member of the Executive Board, Vice Chair since 2002, and Chair since November 2022
- Founding Member of the UK Responsible Person Association (UKRPA)
- Member of the Ethics Committee of the Medical Council for Lower Saxony since 2015
- Member of the Regulatory Affairs Professional Society (RAPS), USA
- Founding Member of the RAPS Germany Chapter
- On behalf of EAAR, member of the Stakeholder Group of the European Union’s Medical Device Coordination Group (MDCG and MDCG-PMSV)
12:05pm - 12:35pm
Plenary
EU MDR Meets Australia: Managing Two Systems
With more than 20 years of experience in the medical device industry, Kellie brings a unique perspective to regulatory affairs, having built her career across marketing, product management, and regulatory functions. Her broad industry experience enables her to understand the regulatory landscape, as well as the practical realities of bringing innovative healthcare solutions to clinicians and patients. Kellie‘s passion for patient outcomes is deeply personal. Growing up with a brother living with a chronic illness gave her an early appreciation of the importance of safe and effective treatment options. That understanding became even more meaningful when her youngest child was diagnosed with type 1 diabetes. Kellie takes great pride in the role regulatory affairs plays in ensuring patients have access to safe, effective, and high-quality medical technologies. She is passionate about making a difference and is a strong advocate for keeping patient needs at the centre of every decision.
Jillianne McKenzie, RAC (EU) Vice President, Regulatory Affairs, Field Orthopaedics Jillianne McKenzie is VP of Regulatory Affairs at Field Orthopaedics, a Brisbane-based medical device start-up developing innovative solutions for hand and wrist surgery. She leads regulatory strategy across multiple jurisdictions, spanning the full product lifecycle. With regulatory affairs experience encompassing medical devices and diagnostics, Jillianne has held roles with global responsibilities at organisations including Alere (now Abbott), Cook Medical and Panbio, and served as Australia’s IVD industry representative to the GHTF, contributing to guidance that continues to underpin regulatory systems used today. A long-time guest lecturer at the University of Queensland and a member of MTAA’s Regulatory Affairs Committee (RAC), she shares insights here from an Australian manufacturer’s perspective for EU MDR Meets Australia.
John Jamieson is the Assistant Secretary, Medical Devices Authorisation Branch at the Therapeutic Goods Administration (TGA). John also represents the TGA on the International Medical Device Regulators Forum (IMDRF) Management Committee and on the Regulatory Authority Council of the Medical Devices Single Audit Program (MDSAP). John’s branch manages the TGA’s conformity assessment certification and comparable overseas regulator reliance arrangements for medical devices, including in-vitro diagnostics and software as a medical device.
12:40pm - 1:30pm
Lunch in the Showcase Arena
1:30pm - 2:25pm
Plenary
Signals & Systems: Post-Market Surveillance in Practice
Post-Market Vigilance Manager at Medtronic ANZ and Co-chair of MTAA Quality Assurance Forum with over 12 years of experience in the medical device industry, supporting patient safety, regulatory compliance, and quality outcomes across ANZ.
Dr Marcelle Noja is Assistant Secretary of the Medical Device Surveillance Branch at the Therapeutic Goods Administration (TGA). She leads national activities relating to medical device safety, post-market surveillance, adverse event investigations and reviews, and regulatory responses to emerging risks. With extensive experience across public health, health protection and therapeutic goods regulation, Marcelle is passionate about fostering collaboration between regulators, industry and healthcare providers to support innovation, patient safety and confidence in Australia’s medical technology sector.
Yuhua is Deputy Director of the Quality Systems, Adverse Events and Compliance Branch at the Medical Devices Cluster, Health Sciences Authority, Singapore. With over 15 years of experience in medical device regulation, she oversees adverse event reporting, dealers licensing, compliance programmes, and ISO 13485 and GDPMDS witness audit programmes. She has been actively involved in international regulatory harmonisation through the International Medical Device Regulators Forum (IMDRF), including work on Unique Device Identification (UDI), Quality Management Systems and Foundational Documents. She contributed to the development of the IMDRF UDI Application Guide and leads Singapore’s UDI implementation. She also serves on Singapore’s National Mirror Working Group for ISO/TC 210 Quality Management.
Erin Skuce is the National Director of the Medical Devices Compliance Program (MDCP) within the Regulatory Operations and Enforcement Branch at Health Canada. She leads Canada’s national post-market regulatory oversight of medical devices, overseeing compliance and enforcement activities, inspections, establishment licensing, and recall reporting to help protect the health and safety of Canadians. Erin holds an Honours Bachelor of Biomedical Science from the University of Guelph and has more than 23 years of experience in Canada’s federal public service. Erin has built extensive expertise in regulatory operations, beginning as a medical devices inspector before progressing through increasingly senior leadership positions across the medical devices, controlled substances, consumer product safety, and cannabis regulatory programs. Prior to her current role, she served as Director of the Strategic Program Support Division within the Cannabis Directorate and as National Director of the Consumer Product Safety Inspection Program. Throughout her career, Erin has been committed to advancing modern, risk-based regulatory oversight, strengthening compliance and enforcement programs, and collaborating with domestic and international partners to support public health and regulatory excellence.
2:30pm - 3:00pm
Plenary
Sustainability by Design: ESG Meets MedTech
Pravin Siriwardena is Policy Manager at the Medical Technology Association of Australia (MTAA), leading policy and advocacy initiatives across environmental, social and governance (ESG), procurement, and industry development. With extensive experience engaging government, healthcare providers and industry leaders, he works to advance policy reforms that support a sustainable, innovative and resilient MedTech sector. Pravin, on behalf of the Australian MedTech industry, has led national industry policy engagement on sustainable healthcare, modern slavery, battery stewardship, circular economy and medical plastics policy. He represents Australia on the Global Medical Technology Alliance (GMTA) Sustainability Committee and is an industry partner on the Solving Plastic Waste Cooperative Research Centre (CRC). In procurement, Pravin has spearheaded MTAA’s policy and advocacy with Australian state health procurement agencies to improve procurement frameworks, contracting practices and market access pathways. He regularly presents on the intersection of sustainability, procurement and innovation, helping organisations develop awareness and capability to engage on ESG policy developments while ensuring suppliers can continue to deliver outcomes for patients and the health system.
3:05pm - 3:30pm
Afternoon tea in the Showcase Arena
3:35pm - 4:05pm
Plenary
The Art of Regulatory Dialogue
Michelle Stewart is a senior marketing and digital leader with more than 19 years of experience driving growth, innovation, and digital transformation. Since joining Device Technologies in 2018, she has played a key role in expanding the company’s digital presence and delivering customer-focused marketing strategies across the MedTech sector. Known for fostering collaboration and enhancing customer experience, Michelle has also led initiatives in social responsibility, community engagement, and diversity, equity, inclusion, and belonging (DEIB). She serves on the Medical Technology Association of Australia’s Code Monitoring and Women in MedTech Committees and holds an advisory role with the B2B eCommerce Association. A recognised thought leader, Michelle is a sought-after speaker at major industry events. Promoted to General Manager of Marketing & Digital in 2019 and Director of Marketing & Digital in 2023, she continues to lead innovation in marketing, digital strategy, and enterprise data, supporting Device Technologies’ ongoing growth and success.
3:05pm - 3:30pm
Registration opens | Afternoon tea in the Showcase Arena
3:35pm - 5:00pm
Concurrent (Student Session)
MedTech Match: Student Career Development Session
Kelly Tsang is Director of the Post-Market Monitoring Section within the Medical Devices Surveillance Branch at Australia’s Therapeutic Goods Administration (TGA). He leads multidisciplinary teams responsible for post-market surveillance of medical devices, including the detection and investigation of safety signals, analysis of device performance and adverse event data, management of emerging supply disruptions, and regulatory responses to protect public health. Prior to joining the TGA, Kelly spent more than a decade in medical device research and development, specialising in biomaterials, medical device coatings and tissue engineering. He holds a Bachelor of Science, Bachelor of Engineering (Hons) and PhD from Monash University and has conducted research at Monash University, CSIRO, Brigham and Women’s Hospital and the Massachusetts Institute of Technology. Kelly was awarded the Fulbright BHP Billiton Postgraduate Scholarship in Science and Technology in 2011 and regularly speaks on medical device regulation, post-market surveillance, risk management, research translation and the safe adoption of innovative health technologies.
With more than 25 years of experience in the healthcare industry, Amanda Plusnin has built a diverse career spanning clinical, technical and commercial leadership roles. Beginning her career in 1999 as a Cardiac Scientist, she has worked across Cardiac Pacing, Interventional Cardiology, Surgical Cardiology and Pharmaceuticals, developing deep expertise in both patient care and healthcare innovation. Today, Amanda is the Field Sales Manager at Terumo Australia, leading a team of six sales professionals across Queensland and Western Australia. She is passionate about developing people, building strong customer partnerships and helping healthcare organisations deliver better outcomes for patients. Her extensive clinical background and commercial experience enable her to connect effectively with healthcare professionals and lead high-performing teams. Outside of work, Amanda is a proud mother of three and a devoted grandmother to baby Archie. She values family, connection and authenticity, bringing these principles into both her leadership style and everyday life.
I am a regulatory affairs professional, working in the industry for 11 years. I studied Chemical Engineering and Masters in Biomedical Engineering at UNSW, which is where my interest in medical devices was really fostered. Since my time at University, I’ve had the privilege of working in tech service at Ecomed, then in regulatory affairs at Device Technologies and now continuing work in Regulatory Affairs at Medtronic. Being able to shape access to medical devices through registrations, participating in TGA consultations and working groups has been a fulfilling journey.
Dr Jiao Jiao Li FRSN FRSB FIEAust is a biomedical engineer and Associate Professor at University of Technology Sydney (UTS). Her research in regenerative medicine develops new approaches including stem cells, bioactive materials, and nanotechnology to treat chronic diseases, particularly bone and joint disorders. National recognitions of her research include 2024 Eureka Prize for Emerging Leader in Science and 2023 Metcalf Prize for Stem Cell Research. Professionally, she serves as a Member of Australian Research Council (ARC) Advisory Committee, Board Director of Australian Institute of Policy & Science (AIPS), and Biomedical College Board of Engineers Australia. Beyond research, she is passionate about promoting STEM education, policy, and engagement, and helping young people become interested in STEM careers.
Brad is the Senior Product Manager for Knee, Primary & Revision at Stryker Australia, where he leads marketing and product strategy for the knee replacement portfolio. His prior experience covers health economics, market access and commercial strategy. Brad holds a Bachelor of Engineering (Honours) in Biomedical Engineering from the University of Sydney and is a Member of the Institution of Engineers Australia, where he serves as an office bearer for the Biomedical College Group, Sydney Division. He is also a mentor in CSIRO’s STEM Professionals in Schools program.
4:10pm - 4:25pm
Plenary
Usability
4:30pm - 5:00pm
Plenary
5:00pm - 5:30pm
MTAA Regulatory Excellence Awards
5:30pm - 7:30pm
Welcome Reception
8.30am
Registration opens | Coffee cart available
Registration opens | Coffee cart available
9:00am - 9:05am
Plenary
Welcome
Acknowledgement of Country
Jasjit Baveja is Director of Regulatory and Industry Policy at MTAA, where she leads regulatory policy development and industry engagement with the Therapeutic Goods Administration. She brings over a decade of hands-on experience in medical device regulation. A long-standing advocate for women in the medical technology industry, Jasjit has co-led women’s network employee resource groups at both Boston Scientific and Johnson & Johnson, and continues to champion gender diversity and inclusion across the sector through her work at MTAA.
9:10am - 9:35am
Plenary
Inside TGA Reform
Australia's regulatory landscape is undergoing significant reform, with TGA implementing changes across pre-market, post-market, and conformity assessment pathways. This session brings together TGA representatives to take stock of what has changed, what is still in progress, and how sponsors and manufacturers should be adapting their regulatory strategies.
Xin-Lin Goh is the Director of the Devices Reforms Taskforce within the Medical Devices and Product Quality Division of the TGA, which was established to finalise and deliver the policy objectives, and progress implementation, of medical device reforms in accordance with An Action Plan for Medical Devices. The Action Plan for Medical Devices is a comprehensive, three-part strategy to strengthen Australia’s medical device regulatory framework while maintaining a strong focus on patient safety, transparency and public confidence. It sets out a programme of reforms to enhance the safety, performance and quality of medical devices, improve access to information, and ensure Australia’s regulatory system remains responsive to the needs of patients, healthcare professionals and industry.
9:40am - 10:05am
Plenary
UDI in Practice: Data, Perspectives and the Path Ahead
Mandatory UDI came into effect from 1 July 2026 for Class III and IIb devices, marking a major shift in how medical devices are tracked and identified in Australia. This session takes stock of how implementation has gone so far, the lessons learnt, how Australia's approach aligns with overseas UDI systems, and what's ahead as UDI requirements extend to lower device classes.
Leanne Etherington is Head of Regulatory Affairs ANZ at Device Technologies, with more than 20 years’ experience in regulatory strategy, applications, and compliance within the medical technology sector. She leads regulatory affairs across Australia and New Zealand, supporting over 1,300 ARTG inclusions and enabling access to innovative medical technologies. Leanne provides strategic leadership across Device Technologies and its group companies, partnering with commercial and operational teams to navigate complex regulatory environments while supporting business growth and patient access. She is recognised for translation of evolving regulatory requirements into practical solutions that deliver both compliance and commercial outcomes. As Chair of the Medical Technology Association of Australia (MTAA) Regulatory Affairs Forum, Leanne works closely with industry and the Therapeutic Goods Administration (TGA) on key regulatory initiatives, including implementation of Australia’s Unique Device Identification (UDI) system. She is passionate about regulatory excellence, mentoring future professionals, and advancing collaboration across the healthcare sector.
Michael Marquez is the UDI Support Team Lead within the Therapeutic Goods Administration’s UDI Program, supporting the implementation and ongoing operation of the Australian Unique Device Identification Database (AusUDID). He works closely with industry, healthcare organisations, regulators and international partners to improve medical device traceability, data quality and the adoption of UDI across Australia. Mic’s interest in this work is shaped by his previous experience as a Registered Nurse and as a Statewide Clinical Product Manager, where he saw firsthand the importance of accurate device information in supporting patient care and safety. He is passionate about helping realise the benefits of UDI for patients, healthcare providers and regulators, and enjoys working collaboratively with stakeholders to drive practical and meaningful outcomes.
10:10am -10:55am
Plenary
Innovation's Front Door: Priority Pathways
This session maps the priority and expedited access pathways available across key jurisdictions, and examines what qualifies a product for these designations, helping attendees understand where opportunity exists and how to build a compelling case.
Professional with 30 years of experience in Medical Device & Pharmaceutical Industry with expertise in Regulatory Affairs, Quality Assurance and Operations.
Dr Jeff Brownscombe is a public health physician, GP and medical manager who is currently the Principal Medical Advisor for the Medical Devices Authorisation Branch at TGA. Jeff also maintains his clinical practice through remote GP telehealth. Jeff’s background includes primary health care, health systems development, clinical governance, medical management, legal medicine, health technology assessment and regulation.
Nada Alkhayat is a Policy Officer at the European Commission’s unit for Medical Devices in the Directorate General for Health and Food Safety (DG SANTE). In her team, Nada holds a horizontal role in the implementation of the medical devices regulations, leading the work on international and chairs the Medical Device Coordination Groups on New Technologies, Nomenclature and International Matters. Her special interest areas include medical device software, Artificial intelligence and in vitro diagnostic medical devices. Prior to joining the European Commission, Nada was a Regulations & Industrial Policy Officer at MedTech Europe.
Dr. Kenneth J. Cavanaugh Jr. has been employed at the U.S. Food and Drug Administration Center for Devices and Radiological Health since 2003 and is currently the Associate Director for International Policy and Strategy. In this role, he oversees the international affairs activities for medical devices and represents the Center on the Management Committee of the International Medical Device Regulators Forum (IMDRF), as co-chair of the IMDRF Good Regulatory Review Practices Working Group, and in multiple international consensus standards development committees. Prior to his current role, he spent over 20 years in FDA’s Office of Cardiovascular Devices as a scientific reviewer, supervisor, and Deputy Office Director.
11:00am - 11:25am
Morning tea in the Showcase Arena
11:25am -12:35pm
Plenary
Lessons Learnt from Around the Globe: The World's Best Ideas
A high-level international regulatory update from attending regulators, each sharing examples of recent successful regulatory initiatives from their jurisdiction.
Dr. Kenneth J. Cavanaugh Jr. has been employed at the U.S. Food and Drug Administration Center for Devices and Radiological Health since 2003 and is currently the Associate Director for International Policy and Strategy. In this role, he oversees the international affairs activities for medical devices and represents the Center on the Management Committee of the International Medical Device Regulators Forum (IMDRF), as co-chair of the IMDRF Good Regulatory Review Practices Working Group, and in multiple international consensus standards development committees. Prior to his current role, he spent over 20 years in FDA’s Office of Cardiovascular Devices as a scientific reviewer, supervisor, and Deputy Office Director.
Yuhua is Deputy Director of the Quality Systems, Adverse Events and Compliance Branch at the Medical Devices Cluster, Health Sciences Authority, Singapore. With over 15 years of experience in medical device regulation, she oversees adverse event reporting, dealers licensing, compliance programmes, and ISO 13485 and GDPMDS witness audit programmes. She has been actively involved in international regulatory harmonisation through the International Medical Device Regulators Forum (IMDRF), including work on Unique Device Identification (UDI), Quality Management Systems and Foundational Documents. She contributed to the development of the IMDRF UDI Application Guide and leads Singapore’s UDI implementation. She also serves on Singapore’s National Mirror Working Group for ISO/TC 210 Quality Management.
Erin Skuce is the National Director of the Medical Devices Compliance Program (MDCP) within the Regulatory Operations and Enforcement Branch at Health Canada. She leads Canada’s national post-market regulatory oversight of medical devices, overseeing compliance and enforcement activities, inspections, establishment licensing, and recall reporting to help protect the health and safety of Canadians. Erin holds an Honours Bachelor of Biomedical Science from the University of Guelph and has more than 23 years of experience in Canada’s federal public service. Erin has built extensive expertise in regulatory operations, beginning as a medical devices inspector before progressing through increasingly senior leadership positions across the medical devices, controlled substances, consumer product safety, and cannabis regulatory programs. Prior to her current role, she served as Director of the Strategic Program Support Division within the Cannabis Directorate and as National Director of the Consumer Product Safety Inspection Program. Throughout her career, Erin has been committed to advancing modern, risk-based regulatory oversight, strengthening compliance and enforcement programs, and collaborating with domestic and international partners to support public health and regulatory excellence.
12:40pm -1:30pm
Lunch in the Showcase Arena
1:30pm – 3:20pm
Plenary
AI in Medical Technology
Speakers from this session join for a moderated panel discussion, covering the practical, regulatory and clinical questions raised throughout the block. Attendees will have the opportunity to put questions directly to the panel.
1.45 - 2.00pm
15 min
15
Entering Medical Device Territory: Lessons from a Technology Company
Angell Zhang is Managing Counsel (JAPAC) at Oracle, with over a decade of legal and regulatory experience spanning private practice and senior in-house roles. She specialises in the regulation of SaMD, digital health and emerging healthcare technologies, advising on legal and regulatory strategy across the product lifecycle and the introduction of innovative healthcare solutions in the JAPAC markets. Angell works at the intersection of law, regulation, healthcare and technology, bringing a practical and commercially focused approach to navigating complex regulatory environments and enabling responsible innovation.
2.00 - 2.15pm
15 min
16
AI in the Quality System: Where It Belongs, and Where It Doesn't
Minta Chen leads Regulatory Affairs, Quality Assurance, and Compliance globally at Harrison.ai, taking AI/ML medical device software through the US, EU, UK, Australian and Asian frameworks. She is passionate in enabling innovative technology in healthcare, and a believer in applying AI to regulatory and quality work itself.
2.15 - 2.45pm
30 min
17
Clinical Evidence for AI-Enabled Products
Heyam Kalla is an experienced medical device regulatory consultant with several years of industry experience, specializing in high-risk devices and clinical evaluation reports. She has expertise in regulatory pathways, planning, and strategy for ANZ and global markets, as well as preparing regulatory submissions, managing regulatory reviews, and supporting post-market compliance for a wide range of devices, including high-risk products. Heyam holds a Bachelor of Science from the University of New South Wales, with a double major in Pharmacology and Medical Microbiology & Immunology, and First Class Honours in Pathology.
Certifying at the Speed of Software
3:25pm - 3:50pm
Afternoon tea in the Showcase Arena
3:50pm - 4:00pm
Plenary
MDSAP: State of the Union
John Jamieson is the Assistant Secretary, Medical Devices Authorisation Branch at the Therapeutic Goods Administration (TGA). John also represents the TGA on the International Medical Device Regulators Forum (IMDRF) Management Committee and on the Regulatory Authority Council of the Medical Devices Single Audit Program (MDSAP). John’s branch manages the TGA’s conformity assessment certification and comparable overseas regulator reliance arrangements for medical devices, including in-vitro diagnostics and software as a medical device.
Jasjit Baveja is Director of Regulatory and Industry Policy at MTAA, where she leads regulatory policy development and industry engagement with the Therapeutic Goods Administration. She brings over a decade of hands-on experience in medical device regulation. A long-standing advocate for women in the medical technology industry, Jasjit has co-led women’s network employee resource groups at both Boston Scientific and Johnson & Johnson, and continues to champion gender diversity and inclusion across the sector through her work at MTAA.
4:05pm - 4:30pm
Plenary
Clinical Trials Landscape Update
4:35pm - 5:00pm
Plenary
Straight to the Source: Therapeutic Goods Administration (TGA)
5:05pm - 5:15pm
Plenary
Closing remarks
Jasjit Baveja is Director of Regulatory and Industry Policy at MTAA, where she leads regulatory policy development and industry engagement with the Therapeutic Goods Administration. She brings over a decade of hands-on experience in medical device regulation. A long-standing advocate for women in the medical technology industry, Jasjit has co-led women’s network employee resource groups at both Boston Scientific and Johnson & Johnson, and continues to champion gender diversity and inclusion across the sector through her work at MTAA.
5:15pm - 6:15pm
Closing Reception
Day 2 End
