Regulatory Affairs Specialist

Job Title

Job Description

Philips is a leading global healthcare company aiming to improve the lives of 2.5 billion people by 2030. We strive to make the world healthier and more sustainable through innovation developed across a broad range of Imaging Information and Monitoring systems.

We are seeking an experienced and driven Regulatory Affairs (RA) Specialist to join our team based in our North Ryde office. As an RA Specialist you will play a pivotal role in guiding our regulatory strategy and managing product registrations ensuring that products meet the required legal and safety standards for market access in Australia. You will work closely with cross-functional teams including R&D quality and marketing to streamline the approval process and support the successful launch of innovative medical technologies.

Your challenge

• Define & execute people centered change strategies making impact by driving adoption of new ways of working.

• Collaborate effectively within the initiative team as well as with initiative stakeholders to identify needs set & execute the regulatory strategy and drive impact while ensuring strategies / plans / activities are aligned with and support the specific to BRF priorities.

• Lead the preparation review and submission of regulatory applications for medical devices to the Therapeutic Goods Administration (TGA) in Australia ensuring compliance with Medical Device Regulations (MDR).

• Maintain up-to-date knowledge of local regulatory guidelines and industry standardssuch as TGA and Medsafe Medical Device Regulations relevant international standards such as: IEC 60601 and other regulatory requirements related to Philips devices. Ensure product compliance with these standards throughout the product lifecycle.

• Oversee the registration process of medical devices with TGA including ongoing post-market surveillance ensuring adherence to regulatory timelines and expectations.

• Work closely with product development teams quality assurance and manufacturing teams to ensure regulatory requirements are met from design through to commercialization.

• Develop and execute regulatory strategies for new and existing products ensuring that all regulatory submissions are clear comprehensive and in compliance with local and international regulations. Ensure compliance throughout the lifecycle of the device including pre and post market requirements.

• Monitor and analyze global and regional regulatory trends to ensure company products are positioned effectively in the marketplace.

• Prepare and maintain detailed regulatory files certificates and other documentation required for regulatory submissions. Ensure timely responses to TGA inquiries or audits.

• Provide regulatory training to internal teams on the latest regulatory developments and best practices.

Youre the right fit if:

• You will bring a Bachelors degree in a relevant scientific or engineering field with at least 8 years of regulatory affairs experience within the medical device industry.

• In-depth knowledge of Australian regulatory requirements including TGA guidelines European Medical Device Regulation (EUMDR) and ISO 13485.

• Experience with medical device classifications product registrations and submission strategies.

• Strong understanding of global regulatory frameworks (e.g. FDA CE Marking).

• Excellent communication organizational and problem-solving skills with the ability to interact effectively with internal and external stakeholders.

• A proactive and results-oriented approach to work with the ability to manage multiple projects simultaneously while ensuring compliance with regulatory timelines.

• Ability to work independently as well as part of a collaborative cross-functional team.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

Philips is an equal opportunity employer committed to building and supporting an inclusive workforce that reflects the diverse communities we operate within. Your application will be fairly assessed regardless of your race religion color national origin gender sexual orientation age marital status veteran or disability status.

Were living this commitment through our Reconciliation Action Plan and employee-led resource groups and we encourage people from all backgrounds including Aboriginal and Torres Strait Islander Māori and Pacific Peoples to apply.

Should you require assistance during your application process due to accessibility reasons we will accommodate this upon request.