Job Information
Philips Senior Regulatory Affairs Manager in Drachten, Netherlands
The Senior Regulatory Affairs Manager plays a vital role in supporting the innovation teams in bringing Beauty & Grooming products to a global market, complying with regulations and standards and with company policies. The Senior Regulatory Affairs Manager will drive the success of a product portfolio that includes household and medical devices, and therefore must navigate a complex and changing regulatory landscape.Collaboration is crucial in this role.
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
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 here.
·Discover our rich and exciting history here.
·Learn more about our purpose here.
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 commitment to diversity and inclusion here.