Reference Number: JO-2307-519448
Device Project Lead
Rate: Negotiable
Job Type: Contract
Location: Cambridge

Regulatory & Quality Device Project Lead

6 Months 

37.5 hours per week

Flexible working from Cambridge 

Offering up to £250.00 Per Hour PAYE 

CPL Life Sciences is collaborating with a pioneering pharmaceutical business who are looking for a Device Project Lead support Class II medical devices. Within this position you will be successfully leading the development of medical devices & combination products. Supporting the team in Cambridge, this contract is initially for a 6 month period. 

Job Responsibilities includes; 

– Planning, co-ordination, risk management and documentation

– Development oversight (market research; user research; concept generation, development and analysis; detail design (e.g. including 3D CAD and engineering drawings); ergonomics and usability (including HF/UE documentation); design reviews).

– Creation and management of Design History Files and associated documentation for selected combination products in accordance with the annual plan and objectives, and relevant standards and guidances e.g. ISO13485, 21 CFR Part 820.30, 21 CFR 3.2(e). etc;

– Management of activities in accordance with project strategies, budget, timelines, regulatory, quality, and professional standards

– Enabling operational excellence in compliance with the current and anticipated professional trends

Candidate Requirements; 

– Eligibility to live and work in the United Kingdom

– Life Sciences degree of equivalent degree 

– Knowledge of GMP and international device regulations;

– Previous experience with Medical Devices and Combination Products 

– Prior Quality and Regulatory knowledge 

If this opportunity is of interest to you please forward your up to date CV to sophie.malyon@cpl.com.

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