Senior Ra Specialist
3 weeks ago
**Key Responsibilities**:
- Plan and execute regulatory activities for global commercial mapping and delivery of certified products
- Manage relationships with regulatory agencies and authorized representatives
- Assess impact of new and updated regulatory requirements
- Support the regulatory requirements for new product development
- Retrospective review of product files
- Product risk management support
- Marketed product controls post-market surveillance
- Generate and support regulatory training to internal teams
**Qualifications & Skills**:
- Minimum of 5 years of experience in Regulatory Affairs in IVD, diagnostics, and/or life sciences
- Degree in a life science or equivalent with significant experience in regulatory affairs
- Strong knowledge and experience of IVDD, IVDR, MDSAP, and QMS ISO 13485
- Experience working with the FDA or other regulatory bodies
- Experience with Notified Body Audits
- Strong organizational skills and ability to work under pressure
- Computer literate with a good understanding of laboratory systems
The company values being patient and customer-centric, equitable, collaborative, innovative, and accountable in its approach to delivering innovative genomic technologies for liquid biopsy diagnostics.
**Job Types**: Full-time, Permanent
**Salary**: £50,000.00-£65,000.00 per year
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Birmingham, West Midlands: reliably commute or plan to relocate before starting work (required)
Work Location: One location
Reference ID: SrRAS QR
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