Global Clinical Evaluation Lead

Corin is seeking a Global Clinical Evaluation Lead who will be responsible for overseeing the preparation of Clinical Evaluation Plans (CEPs) and Reports (CERs), Post Market Clinical Follow-up (PMCF) Plans and Reports, Summary of Safety and Clinical Performance (SSCP), literature searches and appraisals, and for coordinating the wider team of contributors including internal/external stakeholders. The position will collaborate with PCTs and will input pre-market clinical requirements, and post-market clinical follow-up (PMCF) activities, review clinical evaluations, participate in the assessment of clinical benefit-risk profile and support post-market surveillance (PMS) activities. This position will contribute to interpreting results of clinical investigations (pre- and post-market) in preparation for device applications and may serve as an SME to marketing or research and development teams and Regulatory Authorities.

Corin\’s head office is in Cirencester UK, however, if candidates are not local to Gloucestershire we will consider candidates on a remote basis.

The key responsibilities of the Global Clinical Evaluation Lead

• Work directly with the external clinical evaluation team on clinical evaluations and associated documents. Provide training to the external clinical evaluation team, conduct regular meetings and collaborate with them to ensure agreed timelines are met.
• Prepare responses to clinical reviews from Notified Bodies to support product submissions under MDR.
• Review and finalize deliverables for CE marking products under European Medical Device Regulations (MDR) including literature searches and appraisals, Clinical Evaluation Plan and Clinical Evaluation Report, PMCF Plan and Report, and SSCP for accuracy and completeness to ensure compliance with company procedures, templates and regulatory standards.
• Contribute to Post-market and reimbursement activities in global markets including, but not limited to, EU, USA, Australia, Japan, and other distributed markets.
• Participate as key contact from the clinical team to the annual Post-market Surveillance (PMS) meetings of Corin products and provide input into PMS plans and PSURs as required.
• Attend product PCT meetings, providing direction and guidance on clinical requirements for product registrations and/or renewals.
• Work in cooperation with the data management and clinical study functions at Corin to ensure that all inputs from different clinical sources are provided in line with the internal schedule and escalate if delays are identified.

The ideal Global Clinical Evaluation Lead will have:

• Advanced Scientific degree, MD or BS/BA in Sciences/Nursing with the equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Minimum of 3 years related industry experience in Medical Devices or Pharmaceuticals including analyzing, interpreting, and summarizing clinical data for internal and external audiences.
• Understanding of the European Medical Device Directive (MDD) and MDR.
• Experience with post-market clinical follow-up planning and/or post-market surveillance planning is a plus.
• Experience with regulatory submissions utilizing Real World Evidence is a plus.
• Ability to interpret study results and data analyses.
• Proficient knowledge of medical terminology.
• Experience with Literature Review and Appraisal.
• Possess problem-solving skills.
• High attention to detail.
• Able to manage multiple tasks and ensure adherence to timelines.
• Demonstrated ability to communicate effectively both verbally and in writing to represent the department to both internal and external constituencies as required.