Job TitleSenior Regulatory Affairs Specialist

Job Description

In this role, you have the opportunity to

Provide input for regulatory strategy during product creation and contribute to the department’s overall strategy plan.

You are responsible for

Developing and implementing global regulatory strategy and roadmaps through a deep understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategyPlanning, coordination, and preparation of document packages for regulatory submissions to the US, EU, Canada, and Asian countries [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada, CFDA, JPAL]Collaborate with worldwide colleagues regarding license renewals and updatesReview and approve engineering changes, advertising, promotional items, and labeling for regulatory complianceCommunicate application progress to internal stakeholdersMaintain regulatory files and tracking databases as requiredCommunicate with regulatory agencies as neededCreate an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways

You are a part of

A team of regulatory affairs specialists is based in Best (MRI systems), but they are also supporting regulatory activities in Vantaa (MR Therapy) and Gainesville (MRI coils). You will be a part of a multicultural team of enthusiastic people striving for the best regulatory compliance. You will also be able to cooperate closely with Product Development, Clinical Science, and Marketing and Sales.

To succeed in this role, you should have the following skills and experience.

Bachelor/Master of Science degree in a software, technical, or biomedical discipline4-6 years minimum experience in a medical device regulated environment   Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwideExcellent working knowledge of medical device regulations, FDA law, MDD, and other global laws and regulationsKnowledge of the CFDA requirements is a plusExperience in supporting international registrations (FDA) and clinical investigations is a plusRegulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs) is a plusExcellent verbal and written communication skills (English)

In return, we offer you.

We welcome you to a challenging, innovative environment with great opportunities to explore.

Our benefits are very competitive and designed around your preferences:

A market conform salary25 Days of leave and the possibility to purchase up to 20 extra days off annuallyA variable bonus based on both Philips results and personal performanceExtensive set of tools to drive your career, such as a personal development budget, free training, and coachingSolid company pension scheme and attractive collective health insurance packageOpportunity to buy Philips shares and products with a discountHealthy work-life balance

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience various unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To learn more about what it’s like working for Philips personally, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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