Manager Clinical Affairs

Job Description

Role Summary

A Clinical Evaluation Manager (often specializing in medical devices) leads the process of collecting, analyzing, and documenting clinical data to demonstrate a device's safety and performance for regulatory compliance (e.g., EU MDR/MEDDEV 2.7/1 Rev 4). This role acts as a subject matter expert, overseeing medical writers, managing Clinical Evaluation Reports (CERs), and providing strategic input on clinical data requirements throughout the product lifecycle.

Key Responsibilities

• Clinical Evaluation Strategy & Documentation: Develop, maintain, and update Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) plans, and Summary of Safety and Clinical Performance (SSCP).
• Regulatory Compliance & Submissions: Ensure all documentation adheres to regulatory standards (e.g., MDR 2017/745, MEDDEV 2.7/1 Rev 4) and lead responses to notified body questions.
• Literature Reviews & Data Analysis: Conduct systematic, evidence-based literature searches to obtain clinical data, interpreting complex clinical and risk data to assess the benefit-risk profile of devices.
• Team Leadership & Oversight: Supervise or guide medical writers in the creation of CERs, setting project timelines and ensuring high-quality, timely deliverables.
• Cross-functional Collaboration: Partner with R&D, Regulatory Affairs, Quality Engineering, and Marketing to ensure alignment on product safety and performance, acting as a core team member for new product development.
• Risk Management Support: Contribute to risk assessment activities, including updating risk analysis based on clinical data.

Required Qualifications & Skills

• Education: Bachelor's or Master's degree in Life Sciences (e.g., Biomedical Engineering, Nursing, Medicine, Pharmacy).
• Experience: 2–5+ years in medical writing, clinical research, or regulatory affairs within the medical device industry.
• Regulatory Knowledge: In-depth understanding of EU MDR (2017/745), MEDDEV 2.7/1, and ISO standards (ISO 14971, ISO 14155).
• Technical Writing: Proven ability to produce, review, and edit scientific, clinical, and regulatory documents.
• Analytical Skills: Strong ability to interpret complex clinical data and peer-reviewed literature.
• Project Management: Demonstrated ability to manage projects, meet deadlines, and work with cross-functional teams.

Preferred Qualifications

• Advanced Degree: PhD, MD, or PharmD.
• Certification: RAC (Regulatory Affairs Certification) or PMP (Project Management Professional).
• Specific Device Knowledge: Experience in specialized fields (e.g., Cardiovascular/Structural Heart).