Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Eu mdr 2017/745
Medical device regulations
Clinical evaluation reports
Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverables and project timelines and ensure timelines are met
Job Summary
Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverables and project timelines and ensure timelines are met.
Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams.
Matching Summary
Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverables and project timelines and ensure timelines are met.
Salary
Base: $90,000.00 – $180,000.00; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
EU MDR 2017/745
Medical device regulations
Clinical Evaluation Reports
Regulatory Affairs submissions
Vascular product lines
Nice-to-have
Strong command of medical terminology
Adapt to shifting priorities
Deliver high-quality work
Highly-developed interpersonal skills
Key Requirements
Bachelors Degree (± 16 years) OR equivalent education/experience
Minimum 5 years Medical devices, clinical research experience