Manager Clinical Affairs

Zydus Group; Ahmedabad District; On-site; INR 1,400,000 - 2,300,000; Full time

Job summary

Zydus Group is seeking a Clinical Evaluation Manager to drive the collection, analysis, and documentation of clinical data for regulatory compliance of medical devices. You will oversee CERs, SSCPs, and PMCF plans, while coordinating with medical writers and cross-functional teams to ensure timely and high-quality deliverables.

The role requires strong regulatory knowledge (EU MDR/MEDDEV), literature review skills, and experience in risk assessment to support product lifecycle decisions and

Qualifications

• Education in Life Sciences or related field is required (Bachelor’s or Master’s).
• Strong regulatory knowledge of EU MDR, MEDDEV, and ISO standards is essential.
• Proven ability to produce, review, and edit scientific and regulatory documents.
• Experience in clinical data interpretation and risk assessment is important.
• Ability to lead and coordinate medical writers and cross-functional teams.

Responsibilities

• Develop, maintain, and update CEPs, CERs, PMCF plans, and SSCPs.
• Ensure documentation adheres to regulatory standards and respond to regulatory bodies.
• Conduct literature reviews and interpret clinical data to assess benefit-risk.
• Lead or guide medical writers in CER creation with timelines.
• Collaborate with R&D, Regulatory, Quality, and Marketing for product safety.
• Support risk management activities with clinical data updates.

Skills

Regulatory knowledge

Technical writing

Analytical skills

Project management

Cross-functional collaboration

Clinical data interpretation

Education

Bachelor’s or Master’s in Life Sciences

Job description

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).