Zydus Lifesciences, we nurture a culture of innovation, excellence, and inclusivity, driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity, we constantly exploring new ways to improve patient care and expand healthcare accessibility. Our commitment to a positive and empowering work environment has earned us recognition as one of India’s Best Workplaces in Biotechnology & Pharmaceuticals.
Post : Clinical Evaluation Manager
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.
Candidate Profile
• 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).
Additional Information
Experience : 2–5+ years
Qualification : Bachelor’s or master’s degree in Life Sciences
Location : Ahmedabad, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th September 2026
Clinical Evaluation Manager : Apply Online
