Regulatory Affairs Specialist 3

Job Title

Job Description

Regulatory Affairs Operations Specialist 3

Leads global regulatory strategy implementation and product compliance planning, guiding design teams and influencing cross-functional projects to ensure successful new product introductions and lifecycle compliance with minimal supervision.

Your role:

Here’s the information distilled into 5 clear bullet points:

• Implements global regulatory strategies and roadmaps, aligning with market and product strategies to ensure compliance across the product lifecycle—including regulatory planning for new product introductions, product changes, and continuous improvement processes.

• Leads safety risk assessments, manages regulatory incidents and corrective actions, and creatively resolves moderately complex regulatory issues while upholding high performance and accountability standards.

• Partners with regional and central regulatory teams to support product registrations, UDI/GTIN activities, and witness testing; prepares and validates regulatory submissions and justifications to expedite global approvals.

• Maintains direct contact with certifying bodies and local regulatory personnel; supports the development and communication of regulatory standards, including safety and compliance requirements for I&D and OEM/ODM products.

• Recommends system and SOP enhancements, reviews and approves labeling and marketing materials, and oversees compliance processes within PDLM and MLD to ensure international regulatory standards are met.

You're the right fit if:

• Bachelor's degree in biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.

• Minimum 2 years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent OR no prior experience required with master's degree.

• Advanced English Level

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.

This role is an office role.
 

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.

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