Vacancy expired!
- 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/Postproduction 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 Postproduction 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.
- 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 (EU 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
- Bachelor’s or master’s in health-related fields
- Excellent understanding of clinical trial regulations, Google Cloud Platform, MDR, MDCG etc.
Vacancy expired!