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 alex@zenopa.com <mailto:alex@zenopa.com>

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