Medical Writer Job – Remote India | Kelly SETT

Kelly Science, Engineering, Technology & Telecom (Kelly SETT) is hiring a Medical Writer for a 12-month fixed-term contract (full-time) to support medical device (spinal devices) projects. This remote Medical Writer job in India is ideal for professionals with experience in Clinical Evaluation Reports (CERs), systematic literature reviews, and EU MDR/MDCG regulations.

This opportunity allows you to work closely with cross-functional scientific and regulatory teams while contributing to high-impact regulatory documentation in the medical device industry.

Key Responsibilities – Medical Writer (Medical Devices)

• Author, update, and manage CERs, SSCPs, SOAs, and Literature Review Reports (LRRs)
• Conduct systematic literature reviews (search, screening, data extraction, analysis, synthesis)
• Perform risk–benefit analysis using clinical and non-clinical evidence
• Compare device safety and performance against State of the Art (SOTA)
• Investigate unexpected clinical or post-market outcomes
• Use tools such as MS Office, EndNote, Distiller, Wrike, and internal AI platforms
• Collaborate with Medical Directors, PMS, R&D, Design Quality, and Regulatory Affairs
• Ensure compliance with MEDDEV 2.7.1 Rev 4, EU MDR, MDCG guidelines
• Communicate project risks, timelines, and opportunities to stakeholders

Required Qualifications & Experience

• Bachelor’s degree (BA/BS/BSN) in life sciences; advanced degree preferred
• Minimum 3 years of medical writing experience
• Hands-on experience with CER writing and literature reviews
• Knowledge of medical device regulations, clinical research, and compliance
• Familiarity with adverse event reporting and PMS is an advantage
• Strong writing, communication, project management, and prioritization skills

Preferred / Desirable Skills

• Experience in medical devices (spinal or implantable devices preferred)
• Strong understanding of EU MDR, MDCG, MEDDEV 2.7.1 Rev 4
• Background in Dentistry, Optometry, Veterinary Science, or related life sciences
• Proven ability to analyze clinical performance and safety data

Salary & Benefits

• Salary: ₹6,00,000 – ₹12,00,000 per annum (INR, based on experience)
• 100% remote work (India)
• Exposure to global medical device regulatory projects
• Collaborative, cross-functional scientific environment
• Contract role with potential for extension

How to Apply

Application Link