Job Title: Senior Clinical Evaluation Medical Writer
Location: Nanakramguda, Hyderabad, India (Hybrid)
Job Requisition ID: R48074
Employment Type: Full-Time
Posted On: Yesterday
About Medtronic
At Medtronic, you can build a lifelong career of exploration, innovation, and meaningful impact. We are driven by a mission to alleviate pain, restore health, and extend life, while advancing healthcare access and equity across the globe.
Join a team of 95,000+ professionals who are passionate about creating real solutions for real people — from the R&D lab to the operating room. We lead the way in healthcare technology, engineering the extraordinary through collaboration, innovation, and compassion.
Position Summary
The Senior Clinical Evaluation Medical Writer will support the Surgical Operating Unit (OU) by preparing and maintaining high-quality Clinical Evaluation Reports (CERs) and Periodic Safety Update Reports (PSURs).
This role requires a deep understanding of medical device regulations, clinical documentation standards, and post-market surveillance activities. The ideal candidate will combine scientific expertise with strong writing and analytical skills.
Key Responsibilities
Author, edit, and review regulatory and clinical documents, including:
Clinical Evaluation Reports (CERs)
Clinical Study Reports and Summaries
Summary of Safety and Clinical Performance (SSCP)
Periodic Safety Update Reports (PSURs)
Responses to Notified Bodies
Collaborate daily with cross-functional teams, providing evidence-based, solution-oriented input.
Partner with regulatory affairs and medical experts to ensure accurate and timely PSUR submissions.
Monitor and interpret evolving safety regulations and global standards to ensure compliance.
Conduct post-market surveillance (monthly literature reviews) and analyze product safety/performance data.
Perform proofreading, editing, formatting, and version control of all medical writing deliverables.
Manage and maintain applicable databases for clinical evaluations and post-market surveillance.
Support preparation of new product literature and updates to existing documentation.
Engage proactively with peers to share insights and promote collective learning.
Apply knowledge of relevant standards, including ISO 13485, ISO 14971, and EU MDR.
Required Qualifications
Education: B.E. or B.Tech in Mechanical or Biomedical Engineering.
Experience:
Minimum 6–8 years in Quality/Clinical Engineering roles.
8–12 years total professional experience in the medical device or healthcare domain.
Strong understanding of:
Clinical Evaluation Reports (CERs) and Post-Market Surveillance (PMS) processes
Adverse Event Reporting procedures
Regulatory standards: ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 11, and EU MDR
DMAIC or DMADV (DFSS) methodologies
Preferred Knowledge & Skills
Excellent written and verbal communication skills, including technical writing and report preparation.
Experience with FDA Quality System Regulation and auditing processes.
Strong grasp of risk management principles and hazard analysis in the context of medical devices.
Familiarity with Literature Review, PMCF, IMDRF coding, CAPA, and NCMR.
Demonstrated ability to collaborate cross-functionally as a contributor, leader, and facilitator.
Proficiency in data interpretation and documentation management.
Additional Information
This is an individual contributor role with responsibility for delivering technical and regulatory documentation.
May provide mentorship to junior colleagues.
The position description reflects general duties and expectations and may evolve with organizational needs.
Compensation & Benefits
Medtronic offers a competitive salary and comprehensive benefits package, including:
Flexible benefits and wellness programs.
Recognition and performance-based incentives through the Medtronic Incentive Plan (MIP).
Opportunities for continuous professional development and global collaboration.
Why Join Medtronic
Be part of a global mission to improve millions of lives.
Work alongside top experts in healthcare technology.
Experience an inclusive culture that celebrates innovation, diversity, and shared success.
Learn more about Medtronic’s mission and culture at:
🌐 www.medtronic.com
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