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About the role
Key responsibilities & impact- Independently create and maintain Clinical Evaluation Plans, Clinical Evaluation Reports, SSCPs, regulatory responses, and related documentation
- Identify, evaluate, and summarize clinical evidence from clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations
- Analyze results for product applications and submissions
- Create, manage, or participate in deliverable timelines using project management tools
- Communicate timelines, project risks, and mitigation strategies with cross-functional teams and medical writers
- Interpret clinical, scientific, risk, and literature data for product applications
- Lead or support regulatory responses to Notified Body questions
- Facilitate document communication among Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P, Marketing, Library Services, Quality Engineering, Post-market Surveillance, Clinical Affairs, Risk Management, Program Management, CROs, medical writers, and physician reviewers
- Provide strategic guidance on regulatory requirements related to clinical data and evaluations
- Support internal and external audits, audit responses, root cause analysis, corrective and preventive actions, effectiveness monitoring, and quality metrics
- Independently make decisions on CER-related regulatory issues
- Execute projects within budgetary guidelines
Requirements
What you’ll need- A college degree (Bachelor’s) is required
- Scientific/research background; training and degree in science, engineering, or medical fields
- Understanding of research design, methodology, and statistics
- Thorough understanding of EU MDR 2017/745, MDD 93/42/EEC, AIMDD 90/385/EEC, MEDDEV 2.7/1 Rev 4, MDCG Guidances, SSCP, PMCF plans and reports, and international harmonized standards and guidelines related to medical devices, clinical studies, and quality systems
- Project management experience
- Excellent written, verbal and presentation skills in relevant areas of clinical/technical applications
- Strong command of medical and surgical terminology
- Demonstrated ability to identify and adapt to shifting priorities and competing demands
- Proven ability to deliver high-quality work within tight timelines
- Highly-developed interpersonal skills and strong attention to detail
- Able to travel as needed
Benefits
Comp & perks- Career development with an international company
- Free medical coverage in the Health Investment Plan (HIP) PPO medical plan for qualifying employees
- Retirement savings plan with a high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit
- Equal Opportunity Employer