Biological Compliance Team Leader (Biological Evaluation)

Role – Biological Compliance Team Leader (Biological Evaluation)                

Location – Close to Swindon

Rate – Competitive in line with skills and experience

Type – Permanent

Company summary:

My client is a leading orthopedic medical device organisation have an urgent requirement for a talented Biological Compliance Team Leader. In this role you will be in charge of assessing the bilological impact of a medical device in line with IS) 10993.

Responsibilities:

• Monitor and validate all aspects of sterility assurance including ISO Class 7 cleanroom, gamma irradiation and ETO sterilisation, cleaning and sterilisation of reusable instruments and managing a small team.
• Biologically evaluate the global portfolio of medical devices, including reusable instruments, single use instruments and orthopaedic implants.
• Provide support to global teams for sterility assurance and biological evaluations.
• Manage and support projects
• Ensure products are compliant with the ISO 10993 series.

Requirements:

• A background in Microbology, Biology and/or Biochemistry
• Proven experience with 21 CFR 820.75, ISO 13485, MDD, MDR, ASTM, ISO 19227, ISO 14971.
• Extensive experience of working with the ISO 10993 series



To Apply

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)20 3928 6631 or email on mowusu-ansah@planet-pharma.co.uk 

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Agency providing Global Staffing services.