Medical Writer (EU MDR)

Role overview

An opportunity is available with a US-based product company for a Medical Writer role focused on clinical and regulatory documentation for medical devices. The position is based in Gurgaon or Bangalore and involves close collaboration with teams across regulatory, clinical, quality, marketing, research, and development functions.

Key responsibilities

• Create submission-ready clinical and regulatory documents, including clinical evaluation documents, PMCF documents, Summary of Safety and Clinical Performance documents, and clinical study documentation.
• Collect, review, and combine evidence from clinical trials, post-market follow-up data, literature reviews, meta-analyses, ad hoc analyses, and other available safety and performance sources.
• Develop, update, and maintain Clinical Evaluation Reports for new devices, including periodic refreshes, gap assessments, and revisions of existing reports.
• Support EU MDR documentation by contributing clinical input to design and documentation activities in collaboration with cross-functional teams.
• Assist with clinical study protocols and reports by preparing data summaries from raw data and helping shape document strategy.
• Perform literature searches, interpret findings, and translate them into clear scientific content for regulatory documents.
• Coordinate document review cycles, manage feedback, and lead discussions related to revisions and final approval.
• Resolve document content questions, challenge assumptions where needed, and help improve internal procedures, templates, and style standards.
• Act as a knowledge resource within the team and identify schedule or resource conflicts early, proposing practical solutions.

Requirements

• Bachelor’s degree is mandatory, preferably in a scientific field; a Master of Science in a scientific discipline is preferred.
• Overall experience should fall between 2 and 8 years.
• At least 2 years of exposure to healthcare products or medical devices is required.
• At least 1 year of prior medical writing experience in the healthcare product or medical device space is required.
• Experience with MEDDEV 2.7/1 Rev. 4 and EU MDR 2017/745-compliant clinical evaluations is preferred.
• Strong scientific writing and medical writing capability is essential.
• Ability to analyze scientific literature and clinical study data and present it in a precise, accurate, and easy-to-understand format.
• Comfort working with internal and external stakeholders such as regulatory teams, marketing teams, R&D, physicians, CROs, and medical staff.
• Working knowledge of clinical operations, risk management, regulatory submissions, and US/international guidelines is preferred.
• Ability to use ISO, FDA, and related standards to guide documentation and writing approach is preferred.

Additional information

• Location options: Gurgaon or Bangalore.
• Experience range: 2 to 8 years.
• Notice period requirement: immediate joiners to a maximum notice period of 30 days.
• Communication note: candidates were asked to reply with an updated profile and not alter the subject line in their response.
• Information requested from candidates included total experience, relevant experience in medical writing and related EU MDR/CER/PMCF/SOTA areas, medical device industry experience, current CTC, expected CTC, official notice period, willingness to work in Gurgaon/Bangalore, and interview availability on weekdays for F2F or MS Teams rounds.