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QA/RA Manager

Cambridgeshire   •  Negotiable  •  Permanent, Full time


Job Title: Regulatory Affairs (RA) Associate

Reporting To: Technology Development Manager

Location: Cambridge

Summary

The RA Associate is responsible for supporting the regulatory obligations of the organisation and its products throughout the full product lifecycle.

Key Responsibilities

Duties

* Input to regulatory aspects of technology & product opportunity evaluation.
* Lead regulatory aspects within the product development process e.g. requirements capture, standards identification and interpretation, planning and conduct of verification & validation activities, clinical evaluation and investigations.
* Liaise with global regulatory authorities regarding product certification.
* Compile and maintain product Technical Files for initial and ongoing product certification.
* Coordination of post-market activities e.g. surveillance, customer feedback, failure analysis.

Person Specification

Knowledge & Experience

* Working within an ISO 13485 Quality Management System under the Medical Devices Directive (MDD)/Medical Devices Regulation (MDR) for product development and/or manufacturing in the UK/EU is essential.
* Knowledge of US FDA 21 CFR 820 Quality Systems Regulation is desirable.
* Knowledge and experience of the medical device EU CE marking process and MDD/MDR is essential.
* Knowledge of the US FDA product approval process e.g. 510k is desirable.
* Experience of Class I and II devices is essential, Class III is desirable.

Education

* A degree or higher degree in an Engineering, Science or Regulatory discipline; or equivalent.


You must be eligible to work in the UK. Learn more

  • Agency: SRG
  • Contact: Bec Johnston2
  • Phone: 01223 235203
  • Reference: J32671
  • Posted: 8th November 2019
  • Expires: 29th November 2019

SRG

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