Philips Regulatory Affairs Engineer in Best, Netherlands
The Regulatory Affairs Specialist (RA specialist) is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The RA specialist also provides strategic input during product creation process and contributes to the department’s overall regulatory strategy plan. At Philips MRI the RA Specialist cooperates closely with Product Development , Clinical Science and Marketing and Sales.
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.
Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU and/or Canada [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada].
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
You are part of a team of Regulatory Affairs Specialists based in Best and Gainesville. You will report to Sr. Manager Regulatory Affairs. It’s a multicultural team and they are all enthusiastic people striving for the best regulatory compliancy.
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
We offer a market conform salary
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
We are looking for
Bachelors/Master of Science degree in a software, technical, or biomedical discipline
Minimum of 4-6 years of 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
Experience in supporting international registrations (FDA) and clinical investigations (preference)
Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs). (preference)
Knowledge of the CFDA requirements. (preference)
Excellent verbal and written communication skills (English)
Enthusiastic, self-motivated regulatory professional
Good communicator and team player who is able to work in a flexible and goal oriented environment
Structured way of working
Problem solving and time management skills
After a pre-selection process on your resume you will receive an invite for an introduction meeting by phone. If positive, you will be invited for (face-to-face) interviews.
If you have any remaining questions regarding this vacancy, please do not hesitate to contact Annette van Kamp-Rustenburg on tel +31-625714986