Senior Clinical Evaluation Medical Writer – Hybrid – Hyderabad (Nanakramguda)
Location: Nanakramguda, Hyderabad, India
Job Type: Full-Time | Hybrid
Requisition ID: R37815
Posted: 15 Days Ago
About the Role:
Medtronic is seeking a Senior Clinical Evaluation Medical Writer to join the Endoscopy team, contributing to the creation, revision, and maintenance of clinical documentation for CE Mark submissions and compliance with EU MDR 2017/745. This role requires deep scientific writing expertise, a firm grasp of EU regulations, and the ability to collaborate across functions.
Key Responsibilities:
Develop and maintain Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up Plans (PMCFPs), Reports (PMCFRs), and SSCPs in compliance with MEDDEV 2.7/1 Rev 4, EU MDR 2017/745, and internal procedures.
Conduct literature reviews and analyze clinical, safety, and performance data to support regulatory submissions and lifecycle documentation.
Support Medical Information operations by tracking inquiries, creating literature-based responses, and managing documentation.
Review abstracts, posters, slide decks, manuscripts, and promotional materials to ensure regulatory and scientific accuracy.
Collaborate with Regulatory Affairs, Clinical Affairs, Quality, and Risk Management teams to ensure alignment on product risk and safety data.
Identify and escalate adverse events/complaints from literature to the Global Complaint Handling team.
Develop state-of-the-art reports and ensure accuracy of IFUs, risk management files, and labeling content.
Maintain databases of peer-reviewed literature and respond to audit and regulatory authority queries.
Communicate progress, deadlines, and challenges with stakeholders in a proactive and timely manner.
Required Qualifications:
Bachelor’s degree with 8+ years of total experience including minimum 4 years of relevant experience, or Master’s/advanced degree with 2+ years of relevant experience.
Mastery of clinical evaluation processes, literature review methods, and regulatory documentation under EU MDR.
Familiarity with project management practices.
Excellent command of scientific writing, critical data analysis, and literature synthesis.
Preferred Skills:
Expertise in medical devices or endoscopy domain.
Experience working with cross-functional global teams.
Strong attention to detail and ability to simplify complex data into clear, compliant documentation.
Work Environment:
Hybrid work model with flexibility to operate from Medtronic’s Hyderabad campus.
Role requires working collaboratively across global time zones.
Benefits & Compensation:
Competitive salary and Medtronic Incentive Plan (MIP) eligibility.
Extensive benefits package including health, wellness, stock purchase, and career development.
Inclusive and innovative workplace focused on diversity, collaboration, and professional growth.
About Medtronic:
With a mission to alleviate pain, restore health, and extend life, Medtronic leads global healthcare innovation. Home to 95,000+ professionals worldwide, the company blends advanced R&D with patient-first principles to develop technologies that change lives. At Medtronic, you don’t just work on medical solutions—you engineer the extraordinary.
Estimated Salary: ₹14 – ₹23 LPA (based on experience and industry benchmarks)
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