CK Group are recruiting for a Medical Device Risk Management Specialist to join a company in the Pharmaceutical industry at their site based in Great Abington on a contract basis for 12 months.
Our client is one of the largest bio-pharmaceutical companies operating in the UK. They are committed to working with the NHS, academia and other healthcare organisations to improve the delivery of healthcare and achieve the best health outcomes for people in the UK.
This Medical Device Scientist role will be based at our clients site in Great Abington, Cambridgeshire.
Up to £20.79 per hour PAYE / £23.30 per hour Umbrella.
Medical Device Risk Management Specialist Role:
- Provide risk management subject matter expertise, ensuring consistent implementation of applicable processes and standards across the product portfolio, in addition to the facilitation and documentation of specific risk management activities.
- Lead risk management activities for combination product and medical device development programmes.
- Support and facilitation of effective risk management activities internally, at external design companies, and at manufacturing facilities/CMOs.
- Generation, approval, and retention of risk management documentation.
- Provide input and support to design validation and support the generation of all regulatory submission data and content.
- Educated to degree level or above in a relevant scientific or engineering discipline with experience of working with combination or device products in risk management.
- Experience of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Familiarity with Human Factors Engineering - Usability Engineering and device assembling manufacturing processes.
- An understanding of GMP.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55476 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 55476
Website: CK Group
- Posted: 22nd May 2023
- Expires: 19th June 2023