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.
- 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.
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