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Quality Manager - Diagnostics-Regulatory-ISO13485-Beds £35-£45k
- Bedfordshire, South East England
- £35,000 - £45,000 per annum
- 2 applications
- Job type: Permanent, full-time
- Date:
- Reference: 21152015
Our client is developing novel disruptive technology on Point of Care Diagnostics with a B2B business model. This lead role has been created to establish the essential procedures and practices that will be required to ensure compliance and the highest standards of products produced. This role is very much "hands on", defining and creating the Quality and Regulatory policy, processes and procedures, complying with ISO9001 and ISO13485, required to grow a new company.
As the successful candidate you should ideally have a life sciences degree together with previous experience in the diagnostics industry quality and regulatory function. This role would ideally suit a candidate who has had a leading role in a larger team within an established diagnostic/medical device company and is looking for the next level of responsibility. Knowledge and experience of ISO 13485, ISO 9001 and FDA approval is essential as is previous involvement in regulatory affairs.
To succeed in this role you must be highly motivated and able to work either on your own initiative or as part of a small team.
Occasional international travel will be required.
Salary range £35,000 - £45,000 plus benefits
As the successful candidate you should ideally have a life sciences degree together with previous experience in the diagnostics industry quality and regulatory function. This role would ideally suit a candidate who has had a leading role in a larger team within an established diagnostic/medical device company and is looking for the next level of responsibility. Knowledge and experience of ISO 13485, ISO 9001 and FDA approval is essential as is previous involvement in regulatory affairs.
To succeed in this role you must be highly motivated and able to work either on your own initiative or as part of a small team.
Occasional international travel will be required.
Salary range £35,000 - £45,000 plus benefits
