Regulatory Affairs Team Lead
2 weeks ago
FPSG are delighted to be retained on a search for a full-time Regulatory Affairs team lead to join our key client based in Glasgow. This role is responsible for leading the compliance team with in this medical device organisation.
**JOB REQUIREMENTS**
- Preparation of regulatory documentation and submissions for product approvals
- Development of regulatory plans/strategies for new products and changes to existing products
- Participation in Design Control, Risk Management activities
- Production and review of design dossiers, technical files and change assessments including custom made devices
- Review and preparation of regulatory paperwork in accordance with International standards and new regulations
- Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations
**QUALIFICATIONS & EXPERIENCE**
***
- Experience in team/ project management/ custom made devices is desired
- Experience with quality engineering and/or MDR is required
- Able to communicate with external parties: Customers, Distributors,
- Able to communicate with personnel in QA/R&D and other departments
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