Main characteristics
- Location
- Derby, Derbyshire
- Company
- Cure Talent Ltd
- Salary
- £90000 - £110000/annum
- Employment type
- Permanent
- Category
- Medical / Pharmaceutical / Scientific
Job summary
Cure Talent is delighted to be working with a market leading Medical Device Manufacturer who specialise in the field of Surgical Products. Due to their continued exceptional growth, we have an exciting opportunity for a Head of RAQA to join them in Derby.As the new Head of RAQA, you will be responsible for the leadership of an established Regulatory & Quality team, ensuring the continued adherence to regulatory requirements and compliance, taking ownership of the QMS and creating and implementing regulatory strategies.
To be successful as the new Head of RAQA, you will have proven experience in Medical Device Regulatory Affairs & Quality Assurance Leadership, developing and growing teams with exceptional knowledge and experience of Medical Device standards and regulations for the UK, EU and wider regions.
Key Responsibilities
* Site leadership of Regulatory Affairs and Quality Assurance, including the QA & RA Teams
* Create, implement and enforce Regulatory Affairs Policies & Procedures
* Create and implement Regulatory Strategy
* Take ownership of the site QMS, ensuring continued compliance and development
* Manage Post Market Surveillance, Adverse Event Report and Product Quality
Experience, Qualifications and Knowledge
* Degree educated in Science or Engineering discipline
* Proven experience in an RAQA Leadership role within Medical Devices
* Exceptional knowledge and experience of Medical Device Standards & Regulations (EUMDR, ISO 13485, ISO 14971, CFR 820, MDSAP)
* Proven experience in implementing/developing an ISO 13485 QMS
* Proven experience and knowledge of PMS, Adverse Event/Incident Reporting
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