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Medical Device Technical/Regulatory Reviewer
BSITechnical/Regulatory Reviewer for medical device QMS audits, supporting ISO 13485 certification globally. Join BSI's Regulatory Services team and make a difference in quality management worldwide.
About the role
Key responsibilities & impact- Provide support of the ISO 13485 certification and CE schemes, for example investigating customer appeals, report reviewing and supporting activities during regulator audits
- Deliver certification decisions for ISO 13485 certifications as eligible, with a goal to being qualified across all non-CE schemes, where resource allows
- Competence verifier activities to support the auditor qualification process
- Support the roll out of policy decisions and processes for medical device QMS audits globally
- Participating in smaller improvement projects ensuring appropriate adherence to procedures
- Provide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing and other BSI colleagues on BSI QMS requirements for medical devices
Requirements
What you’ll need- Previous experience of co-ordinating or conducting audits of medical device manufacturers to ISO13485 (e.g. supplier or internal audits)
- Minimum of two years of hands-on manufacturing experience and two years quality management experience
- First or second degree in engineering, science or related discipline
- A good understanding of QMS requirements as applied to medical devices including applicable regulations and standards (ISO 13485 and MDD, AIMD and/or IVDD, MDR/IVDR and MDSAP requirements in particular)
- A good understanding of product and QMS certification concepts and principles
- A comprehensive understanding of quality systems, philosophies and principles
Benefits
Comp & perks- Competitive total reward package
- Independent and varied job
- Flexible working hours
- Ongoing training and development
ATS Keywords
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Hard Skills & Tools
ISO 13485QMS auditingmedical device manufacturingquality managementregulatory auditscertification decisionscompetence verificationpolicy implementationimprovement projectsquality systems
Soft Skills
advice and supportcommunicationcoordinationcollaborationproblem-solvingattention to detailorganizational skillsinterpersonal skillsleadershipproject management