Job Title: Senior Medical Writer (Medical Devices)
Summary:
4C Pharma, a leading organization in the medical devices industry, is seeking a highly motivated and experienced Senior Medical Writer to join our growing team in Hyderabad. This is a full-time, onsite position requiring immediate joining. The ideal candidate will possess a strong background in medical device regulatory documentation, with specific expertise in CER writing, PSUR, PMS, and EU MDR compliance. If you are a detail-oriented individual with excellent analytical and writing skills, and a passion for ensuring the safety and efficacy of medical devices, we encourage you to apply.
Job Description:
As a Senior Medical Writer at 4C Pharma, you will play a crucial role in creating and maintaining high-quality regulatory documents for our medical devices. You will be responsible for authoring, reviewing, and ensuring the accuracy and compliance of various documents, including Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS) reports, Periodic Safety Update Reports (PSURs), and other documents required for EU MDR compliance. This role requires a strong understanding of medical device regulations and the ability to collaborate effectively with cross-functional teams.
Key Responsibilities:
- Author and review CERs, CEPs, PMCF plans/reports, SSCPs, PSURs, and other regulatory documents.
- Analyze safety data from clinical trials, post-market surveillance, complaints, and adverse events.
- Conduct systematic literature searches, benefit–risk assessments, and hazard analyses.
- Collaborate with cross-functional teams including Regulatory, Clinical, QA, and Medical Affairs.
- Ensure strict compliance with EU MDR, MEDDEV 2.7/2.12, ISO 14155, MDCG and IMDRF guidelines.
- Support internal/external audits and regulatory authority responses.
- Prepare training content and support process improvement initiatives.
- Mentor junior writers and foster knowledge sharing.
Preferred Skills & Experience:
- 1–3 years of experience in medical device regulatory writing or clinical documentation.
- Strong knowledge of PSUR, PMS, CER, CEP, PMCF, and MAUDE database.
- Excellent analytical, scientific writing, and communication skills.
- Proficiency in Microsoft Office Suite.
- Detail-oriented with a strong understanding of device safety reporting.
Educational Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Sciences, Nursing, or related fields.
- B.Tech/M.Tech in Biomedical, Electronics, or Mechanical Engineering will also be considered.
Work Mode & Location:
- Location: Hyderabad
- Mode: Work from Office
- Experience Required: 2.1 to 4 years
- Notice Period: Immediate to 15 days
Why Join 4C Pharma?
- Impactful Work: Opportunity to work on high-impact medical device regulatory documents that directly contribute to patient safety.
- Global Exposure: Exposure to global regulatory standards under EU MDR, providing valuable experience in a dynamic and evolving field.
- Collaborative Environment: Work with cross-functional medical and regulatory teams, fostering a culture of knowledge sharing and collaboration.
- Career Growth: Clear career progression pathways into advanced regulatory & clinical writing roles within a growing and innovative organization.
Benefits Overview:
4C Pharma offers a competitive salary and benefits package, including:
- Comprehensive health insurance
- Paid time off
- Professional development opportunities
- A supportive and collaborative work environment
How to Apply:
If you meet the qualifications and are excited about the opportunity to contribute to a leading organization in the medical devices industry, we encourage you to apply. Please send your updated CV to [email protected]. We look forward to hearing from you!