Hobson Prior are seeking a Senior Clinical Evaluation Scientist to join a medical device organisation who resolve healthcare issues such as making health care accessible to all patients who are suffering with life threating conditions by reducing cost.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Maintaining relationships between Risk Management function and project team. Clearly communicates pertinent project/function information.
• Works closely with Clinical and R&D to develop common Clinical deliverable criteria and plan justification for no clinical trial or aid in development of clinical trial rationalization plan.
• You will mentor and serve as subject matter expert in key risk management activities; participates as a risk management consultant for complex projects and for grouping similar products into logical and sustainable structure.
• You will produce literature searches on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature to support risk assessment.
• Recognises the need for and/or generates risk management related documents on BSC products to support internal BSC and external regulatory agency requirements.
• Dependent on level, may serve as SME and Function representative in internal and external audits including audit participation, back room SME, preparing audit responses and supporting process improvements resulting from the audit.
• You will establish appropriate scope and comparative information for Clinical Evaluation Reports (CER) and drive generation or updates for those documents. Collaborate with cross-functional partners to obtain additional input to aid in clinical risk analysis

Requirements:

• Educated in Bachelor's degree in Life Sciences.
• Have previous experience working with CERs CE Marks and EU MDRs.
• At least 5 years' experience in Pre Clinical or Clinical Research environment.
• Medical and technical writing experience required regarding medical device products.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.