he 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,
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 our customer 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
- Real knowledge on MDR.
- Working knowledge of medical device regulations other than FDA/MDD
- Knowledge on standards
- Regulatory Affairs Certification
Solliciteer op deze functie