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Job titleEvidence Evaluation Senior Manager
Job typeMeditech
Salary GBP
LocationUK East
Bonus PackageBonus Package
Job description

You will become a key component to supporting the continued transition to EU Medical Device Regulations. Sound exciting? We believe so. Our client is looking for an Evidence Evaluation Senior Manager to join their fast growing and exciting medical technology company in East Yorkshire.  

The company 

This global medical technology company focuses on the invention and application of new technologies across their three franchises. They’re making a difference to patients’ lives through the excellence of their surgical devices and wound care product portfolio.   

This is a great opportunity to join a market leading company that offers a broad range of opportunities that takes the limits off living.   

The role 

As Evidence Evaluation (EE) Senior Manager, you’ll lead and manage a team of EE writers and provide technical guidance on literature reviews, clinical evidence reports, medical writing and general scientific literature evaluation.  

Other responsibilities include: 

  • Leading the completion of Clinical Evaluation Reports (CERs)  

  • Updating best practices for CERs and other documentation 

  • Maintaining a thorough understanding of complex and rapidly changing regulatory requirements 

  • Supporting and managing evidence-based projects within the organisation 

  • Obtaining and maintaining clinical evidence databases and reference  

  • Providing scientific support to other departments including marketing, quality assurance and legal etc. 

The requirements 

You’ll have at least 5 years in an academic or commercial background with a minimum of 3 years of supervisory experience.  

Other experience include: 

  • Understanding of the European regulations for CE marking is essential 

  • Degree level educated in a relevant discipline (Master’s degree or PhD preferred) 

  • Proven experience in performing literature reviews and analysing data sets 

  • Experience working within a medical devices or pharmaceutical organisation in a relevant role 

  • Evidence of writing scientific documents for regulatory submissions 

  • Experience in presenting scientific/clinical evidence in a written and oral manner 

Competences include: 

  • Excellent scientific writing skills 

  • Detail orientated and analytical 

  • Self-motivated and able to lead a team 

  • Excellent communication skills (written and verbal) 

  • Strong computer literacy skills (Microsoft Office) 

  • Excellent time management and ability to work under pressure to deadlines 

  • Knowledge of EU regulatory requirements  

  • Able to travel across the territory (when permitted) 

Important information 

FMC contact for the role: Natasha Szombara (natasha.szombara@fmctalent.com) 

Reference number: 10018 

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    Updated on 2017-08-07T17:04:38+00:00, by Matthew Graham.