Regulatory Affairs Specialist 3

Job Title

Regulatory Affairs Specialist 3

Job Description

Regulatory Affairs Specialist 3

Responsible for driving regulatory strategy, ensuring product compliance, and supporting market access for medical devices across global and high surveillance markets.

Your role:

• •Drive and implement global regulatory strategies and roadmaps, ensuring alignment with product marketing strategies, New Product Introductions (NPI), and requirements in high surveillance countries.
• •Lead regulatory planning and execution across the product lifecycle, including submissions, product registrations (e.g., CE Marking), labeling reviews, and compliance protocols, ensuring adherence to international standards and local regulations.
• •Monitor and manage regulatory risks and product safety by conducting risk assessments, handling compliance issues in systems such as TrackWise, and driving corrective and preventive actions in collaboration with cross‑functional teams.
• •Collaborate with global and regional stakeholders (Regulatory Affairs, Quality, R&D, Marketing) to support regulatory filings, certification processes, UDI/GTIN activities, and continuous improvement of regulatory processes and systems.

You're the right fit if:

• •You have +2 years of experience in Regulatory Affairs, Quality Compliance, or Product Development within the medical devices industry with a Bachelor’s degree, or no prior experience required with a master's degree, preferably knowledgeable in Quality Compliance or similar fields.
• •Knowledge of regulatory requirements, product registrations, risk management, regulatory submissions, labeling compliance, stakeholder management, and continuous improvement methodologies.
• •Experience with high surveillance markets, familiarity with regulatory systems (e.g., TrackWise), strong analytical and problem‑solving skills, and RAPS RAC certification is a plus.
• •Bachelor’s or Master’s degree in Biomedical Engineering, Health Sciences, Pharmaceutical, Business Administration, Law, or a related field.
• •Ability to fluidly communicate in English is required.

How we work together

• We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
• Onsite roles require full-time presence in the company’s facilities.
• Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.t.

This is an in office role with Administrative shift.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't 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.

• •Learn more about our business .
• •Discover our rich and exciting history .
• •Learn more about our purpose .

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here .