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Public Health, Patient Safety

Covering the following locations: Birmingham, Derby, Leicester, Nottingham, Oxford, Reading, Sheffield, Swindon

Zenopa are working exclusively on a Head of Regulatory Affairs role based in the Birmingham. This role will be covering an Oncology Diagnostics portfolio related to Multiple Myeloma and other related diseases.

This is an initial four-month fixed term contract and the responsibilities will include:

· Manages and develops Regulatory, Risk, IP and Ethics staff
· To ensure that company IP is adequately identified, protected and maintained
· Responsible for oversight and prioritization of departmental tasks and projects
· Oversees, manages and implements the preparation of major regulatory filings, including U.S.510(k) CE marking submissions, as well as international dossiers.
· Provides regulatory expertise to development project teams, develops regulatory strategy and execution of strategic plans that are in support of corporate goals and timelines.

You will ideally have:

· Minimum 5 yrs. Regulatory experience
· CE/510(k) Submission experience
· Able to interact with regulatory agencies
· Knowledge of the clinical laboratory environment and the IVD industry
· Record of leading high-performance teams
· Strong knowledge of GMPs/ISO13485/ISO14971

If you would like to receive more information, please contact Alex Martin on 01494818028 or <>

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* Salary Guide
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Job Ref: 65677

Alex Martin

Recruitment Manager 01494 818 028

Tom Summerbell

Senior Account Manager 01494 818 037

Why Zenopa?

  • Long standing relationships

    Zenopa develop strong working relationships with our clients, which means we understand their company and cultural values.

  • Quality Controlled

    Zenopa operate a Quality Management System (QMS) and we're audited to ensure an excellent quality of service.

  • Interview Preparation

    We thoroughly prepare you for all interviews and obtain full, constructive feedback after you've met the client.

  • Support & Advice

    Zenopa provide a constant service. There will always be someone at the end of the phone to answer your questions.

  • Recruitment with Integrity

    We will always provide you with honest, professional advice and fully understand your career needs.

  • Highly Recommended

    Our Customer Service standards are extremely high. We are highly recommended by 96% of clients and 98% of candidates.