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Regulatory Affairs Specialist

Posted on Aug 15, 2019 by Randstad Multilingual Recruitment Banen

Best, Noord-Brabant, Netherlands
Health Care
Immediate Start
Annual Salary

Regulatory Affairs Specialist

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 specialist also provides strategic input during product creation process and contributes to the department s overall regulatory strategy plan. At Philips IGT Systems the RA Specialist cooperates closely with Product Development, Medical Affairs and Marketing and Sales as part of a new product introduction or maintenance project. Often multiple smaller projects at the same time.

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 .
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
Collaborate with worldwide colleagues regarding license renewals and updates as needed(yet normally done by RA international team)
Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
Must have items
Minimum of 2 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
Available in short timeEnthusiastic, self motivated regulatory professional
Structured way of working
Problem solving and time management skills

Nice to have items
o Real knowledge on MDR.
o working knowledge of medical device regulations other than FDA MDD
o Knowledge on standards
o Regulatory Affairs Certification

Max rate senior person is 73 euro.

Reference: 745700767

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