Clinical Evaluation Lead

The contractor will be responsible/accountable for the following,
Act as the primary point of contact for the Clinical project lead and provide support in Life Cycle Management/Post Production risk review activities
Activities include but not limited to, understanding and evaluating available clinical data on surgical products, reviewing data against MDR and MDCG Guidance documents and conducting gap assessments and remediation activities
Provide clinical functional review and expertise on the assigned projects/tasks
Be responsible for timely authoring (as applicable), revisions, update, on clinical related documents for Medical Device Regulation (MDR) remediation and Post production Risk Reviews (PPRRs), and post-market clinical plans
Develop template for post-market clinical plan activities, including physician surveys, retrospective/prospective studies etc.
Review large documents such as literature reports, clinical research protocols, and review template documents as assigned by the project lead/line manager
Assist in literature review activities as assigned by the project lead and/or CDMA Franchise Head
Attend Clinical team meetings, Clinical Sub team and Trial Team Meeting and any other project meetings as assigned by the Project Lead/Line Manager and represent the function
Complete training activities to better understand product therapeutic area as assigned by the manager

Qualifications:
Bachelor's or Masters in Health related fields
Excellent understanding of clinical trial regulations, GCP, MDR, MDCG etc.
Strong experience in clinical evaluations of medical devices (ophthalmology preferred) for life cycle management, and remediation for MDR
Good knowledge of the European medical device regulations (MDR), MDCG and PMCF requirements for medical devices
Prior experience in planning/conducting/reporting physician surveys, registries etc is a bonus
Experience in eye care/ophthalmology is preferred
Strong communication and writing skills Strong project management and meeting facilitation skills