Clinical Evaluation Lead

Job Title

LOCATION: Ideally HM would like 3 positions in Fort Worth and 2 positions in Lake Forest, CA. However, remote is OK but not the preferred method and we need them to be flexible to be able to jump on a plane and be here in FTW (for 2-3 days) if needed.

Job Description Key Accountabilities

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

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.