Freelance Regulatory Affairs Specialist (ZZP)

Regulatory Affairs Specialist

In this role, you have the opportunity to:

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

You are 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

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.

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

• 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)