4C Pharma Hiring For Senior Medical Writer – Medical Devices

4C Pharma is hiring a Senior Medical Writer – Medical Devices for its Hyderabad office. This opportunity is ideal for professionals with 2–4 years of experience in medical device regulatory writing, particularly those with hands-on experience authoring PSUR reports under EU MDR. The role is work from office and open to immediate joiners or candidates with up to 30 days’ notice.

This position offers strong exposure to post-market surveillance (PMS), clinical evaluation, and regulatory compliance, making it a valuable career move for medical writers in the medical devices industry.

Key Responsibilities – Senior Medical Writer Medical Devices

• Author PSUR reports (mandatory), Clinical Evaluation Plans (CEPs), PMCF plans and reports, SSCPs, and other medical device safety documents
• Review and analyze safety data from clinical trials, PMS activities, complaints, and adverse event reports
• Perform literature searches, data interpretation, trend analysis, and hazard/risk-benefit analysis
• Collaborate with Regulatory Affairs, Clinical, QA, and Medical Affairs teams
• Ensure compliance with EU MDR, MEDDEV 2.7 & 2.12, ISO 14155, and internal SOPs
• Support regulatory audits, inspections, and responses to authority queries
• Prepare training materials, contribute to process improvement initiatives, and stay updated on MDCG and IMDRF guidelines
• Mentor junior medical writers and support team knowledge sharing

Eligibility & Qualifications

Education

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or related fields
• B.Tech / M.Tech in Biomedical, Electronics, or Mechanical Engineering may also apply

Experience & Skills

• 2–4 years of experience in medical writing or medical device regulatory documentation
• Mandatory experience in PSUR authoring for medical devices
• Hands-on exposure to PMS reports, CERs, CEPs, PMCF documents, and MAUDE database
• Strong understanding of medical device safety reporting and EU regulatory frameworks
• Excellent analytical, writing, and communication skills
• Proficiency in MS Word, Excel, PowerPoint, and Outlook

Salary & Benefits

• Estimated Salary: ₹8,00,000 – ₹12,00,000 per annum (CTC), depending on experience
• Opportunity to work on global medical device projects
• Structured career growth in regulatory medical writing
• Collaborative, compliance-driven work environment

Job Location & Work Mode

• Location: Hyderabad, Telangana
• Work Mode: Work from Office

How to Apply

Interested and eligible candidates can apply by sending their updated CV to:

📧 sushmitha.r@4cpharma.com