Position: Senior Clinical Evaluation Medical Writer
Location: Nanakramguda, Hyderabad, India (Hybrid)
Job Type: Full-time
Job Requisition ID: R48074
Medtronic is a global leader in healthcare technology, committed to improving access, equity, and outcomes. The company fosters innovation across medical devices, therapies, and solutions to address complex healthcare challenges.
Provide high-quality medical writing, editing, and review of regulatory and scientific documents, including Clinical Evaluation Reports (CERs) and Periodic Safety Update Reports (PSURs) for surgical devices. Support cross-functional teams to ensure compliance with global regulations and enhance post-market surveillance activities.
1. Medical Writing & Document Management
Write, edit, and review regulatory documents: CERs, clinical study reports/summaries, Summary of Safety and Clinical Performance, PSURs, and responses to Notified Bodies.
Prepare manuscripts, abstracts, monographs, scientific exhibits, and other documents for regulatory submission or in-company use.
Conduct literature review for post-market surveillance and product evaluation.
Proofread, format, integrate review comments, and complete documents for submission.
Administer databases related to clinical data evaluation, CERs, and post-market reporting.
2. Cross-Functional Collaboration
Collaborate with regulatory affairs, medical experts, and cross-functional teams to ensure accurate and timely submissions.
Provide solution-oriented recommendations based on data analysis and clinical insights.
Partner with peers to create an environment of knowledge sharing and learning.
3. Compliance & Regulatory Oversight
Monitor evolving safety regulations to ensure PSUR and CER compliance.
Maintain familiarity with ISO 13485, ISO 14971, EU MDR, and product-specific standards.
Apply risk management principles, hazard analysis, and audit practices per FDA, ISO, and EU guidelines.
4. Mentorship & Knowledge Sharing
Act as subject matter expert and mentor to colleagues.
Participate in training and guidance on medical writing, regulatory compliance, and document development.
Education: B.E. / B.Tech in Mechanical or Biomedical Engineering.
Experience: 8–12 years total; 6–8 years in quality engineering or equivalent.
Technical Knowledge:
Clinical Evaluation Reports (CERs) and Post-Market Surveillance (PMS) processes.
Adverse event reporting and ISO/FDA/21 CFR standards.
DMAIC/DMADV (DFSS) methodologies.
Skills:
Strong written and verbal communication, planning, and reporting.
Risk management and hazard analysis for medical devices.
Ability to work independently and as an individual contributor or mentor.
Competitive salary and flexible benefits package.
Eligible for short-term incentive: Medtronic Incentive Plan (MIP).
Career growth, mentorship, and opportunities to contribute to innovation in medical technology.
General office work; not an exhaustive list of responsibilities.
Requires participation in cross-functional projects and collaboration with stakeholders.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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