Quality Assurance & Regulatory Affairs – Medical, Bracknell
This role is for a Quality Assurance and Regulatory Affairs Manager (QARA) in the medical sector, based in the Bracknell area.
Job Details
* Client: [Client information not provided]
* Location: Bracknell
* Job Category: Other
* EU work permit required: Yes
Job Reference:
3014b93c85d4
Job Views:
12
Posted:
28.04.2025
Expiry Date:
12.06.2025
Job Description
Role Overview: We are recruiting a Quality Assurance and Regulatory Affairs Manager (QARA) for a client in the medical sector. This is a new position reporting to the UK Operations Director and the Head of QA/RA in the US. The role involves managing Quality System processes, Regulatory Compliance, and product quality at the UK site, including audits, CAPAs, and process improvements. The role requires close collaboration with US-based teams and may involve 15% travel.
Key Responsibilities:
* Ensure compliance with quality standards and regulations such as ISO 13485, ISO 14971, and EU MDD/MDR
* Coordinate with US Quality teams to align processes
* Lead CAPA activities and manage audit processes
* Handle site-specific audit observations and non-conformities
* Manage FSCA/FA activities and liaise with MHRA
* Support post-market activities and complaint resolution
* Drive continuous improvement initiatives
* Act as the local delegate for the global Management Representative
* Assist in investigating complex quality issues and supporting field actions
Candidate Profile:
* Experience in the medical device sector preferred
* Bachelor’s Degree or equivalent
* Extensive experience in Quality or Regulatory roles
* Strong knowledge of medical device QMS and regulations
* Experience with ISO 13485 and regulatory inspections
* Excellent problem-solving and communication skills
Package: Basic salary £60,000 + bonus, Pension Scheme, Dental Plan
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