Principal- Regulatory Affairs
4 weeks ago
**Regulatory Affairs Principal**
**Overview**
FPSG Life Sciences is delighted to be supporting our key client to recruit a Principal in their Regulatory Affairs team in Glasgow. Experience in medical devices or in Vitro diagnostics would be advantageous. Fantastic opportunity to be a part of a global business undergoing significant growth.
**Responsibilities -**
- Support the RA Senior Manager during surveillance/ recertification audits.
- Lead and deliver regulatory projects.
- Perform, review and sign off on technical documents (RnD) for Custom
- Lead and coordinate activities for RA CAPAs and SATs from initiation to closure
- represent RA and coordinate RA actions in business-wide CAPAs, SATs and Supplier change notifications
- Provide regulatory input to functional groups
- Perform Technical Documentation File reviews prior to submission.
**Experience**
- Experience in team/ project management/ Medical devices is desired
- Able to communicate with external parties: Customers, Distributors,
- Able to communicate with personnel in QA/R&D and other departments
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