Regulatory Affairs Specialist

Regulatory Affairs Specialist (Contract)

Location: Best or a hybrid form is also a possibility 

Duration Assignment: 12 months (with possible extension)

Contract: via a Randstad company

Hours/week: 40

Budget range: €3.836 - €5.115 per month

In this role, you will have the opportunity to: Make life better!

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

When you choose to work at Philips you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve billions of lives around the world.

You will be responsible for: 

• Developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategy

• Planning, 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 updates

• Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance

• Communicate application progress to internal stakeholders

• Maintain regulatory files and tracking databases as required

• Communicate with regulatory agencies as needed

• Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways

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

You will need a customer-first attitude and the following 

• Bachelor/Master of Science degree in a software, technical, or biomedical discipline

• 4-6 years minimum experience in medical device regulated environment

• Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide· Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations

• Knowledge of the CFDA requirements is a plus

• Experience in supporting international registrations (FDA) and clinical investigations is a plus

• Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs) is a plus

• Excellent verbal and written communication skills (English)

You are a part of

A team of Regulatory Affairs Specialists based in Best (MRI systems), but 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 compliancy. You will also have the opportunity to cooperate closely with Product Development, Clinical Science and Marketing and Sales.

In return, we offer you:

For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.