Regulatory Affairs Specialist
3 weeks ago
Job Title:
Quality and Compliance Regulatory Affairs
Job Type:
Permanent position
Edinburgh (Hybrid, 3x a week in the office)
Compliance and Regulatory Affairs Specialist responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems.
Key responsibilities include:
- Initial compilation of design control evidences
- Supplier management
- Incoming inspection and product release process
- Product submission
- Post-market surveillance, vigilance, and associated reporting
Maintain product and site regulatory and quality compliance to ensure license/registration is maintained. Provide training and guidance to other regulatory and quality affairs team members as needed.
Key Skills:
- Regulatory affairs management
- Quality management system implementation
- Medical device compliance
- In vitro diagnostic expertise
Applicants must have a Master's degree or equivalent in life sciences and 3-5 years of experience in a regulatory or quality role.
Requirements:
- Right to work in the UK
- Ability to work in the office 3x a week
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