Philips Senior Regulatory Affairs Manager 

Netherlands, Frisia 

693730636

Your role:

• Keeps up with global and regional regulatory requirements for products and ensures the team is informed about changes, integrating this knowledge into regulatory strategies and plans.

• Drives the implementation of global regulatory strategies for international markets by collaborating with senior leadership.

• Ensures compliance with country-specific regulations for product registration and commercialization by generating and coordinating the submission and approval process.

• Builds and maintains strong relationships with regulatory agencies.

• Provides strategic regulatory direction and requirements to product design teams regarding new products and solutions.

• Liaises with the Post Market Surveillance team to ensure awareness of communications with regulators, supports any necessary escalations related to regulatory issues, and contributes to maintaining compliance by providing necessary documentation and strategic insights.

You’re the right fit if:

• Bachelors/Master of Science degree

• Minimum of 5 years relevant working experience in medical device to regulatory strategy development supporting submissions and product market introductions

• Experienced in leading regulatory affairs projects to create/ensure required content of documentation intended for regulatory submissions

• Working knowledge of medical device regulations such as FDA law, EU MDR and/or other global laws and regulations

• Excellent verbal and written communication skills (English)

• Good communicator and team player who is able to work in a flexible and goal oriented environment

How we work together

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This role is an office role.

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