Job Details

ID #43714905
State Texas
City Fortworth
Job type Contract
Salary USD Depends on Experience Depends on Experience
Source Biogensys
Showed 2022-06-30
Date 2022-06-29
Deadline 2022-08-28
Category Writing/editing
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Clinical Evaluation Lead Specialist with Ophthalmology Products

Texas, Fortworth, 76101 Fortworth USA

Vacancy expired!

Job Description
  • 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

Skills
  • 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

Education
  • Bachelor’s or master’s in health-related fields
  • Excellent understanding of clinical trial regulations, Google Cloud Platform, MDR, MDCG etc.

Vacancy expired!

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