Clinical Evaluation Strategy Specialist

Clinical Evaluation Strategy Specialist
  • £45,000 per Annum
  • Permanent
  • Kingston Upon Hull, East Riding of Yorkshire, England, UK Kingston Upon Hull East Riding of Yorkshire UK HU3 2BN
Job Ref: J2161802
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 09 September 2021
You would be working as part of a huge global medical technology company, leading critical clinical evaluation strategy activities.

You would be working in the Global R&D department as part of the company's orthopaedic area. Working on a global scope, you would be introducing and implementing strategies that will influence market development & launch plans and portfolio decision making and will be key to the company's regulatory and business strategies.

Key Responsibilities:

  • Generation of Post Market Clinical Follow up (PMCF) Plans, clinical data gap analysis, clinical benefits effects analysis (CBEA), and sufficient evidence justifications across multiple franchise/product families to support business objectives and global requirements.
  • Working closely with cross functional groups to develop evidence generation strategies that consider global evidence for regulatory approvals and commercial claims and indications.
  • Working with NPD and marketing teams to establish user needs, claims, indications and market strategies, and develop the evidence strategies to meet those needs
  • Delivering EU MDR documentation and clinical data gap analysis & sufficiency assessments.
  • Interpreting internal and external business issues and regulatory requirements, and drives best practice

The ideal candidate will have a bachelors in relevant discipline, a master's degree or PhD would be desirable. Experience working within the medical devices or pharmaceutical industry in the Research & Development, Scientific and Medical Affairs, Clinical or Regulatory department, preferably in the orthopaedic field. You will also have a strong understanding of evolving post market clinical evidence requirements (EU MDR) and experience developing strategies to generate clinical evidence is beneficial.

09/10/2021 09:38:03
GBP 45000.00 45000.00 Annum

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