Senior Medical Writer – Medical Devices
Company: 4C Pharma Solutions
Location: Hyderabad, India
Employment Type: Full-Time (Work From Office)
Job Overview
4C Pharma Solutions is seeking a skilled Senior Medical Writer – Medical Devices to support global regulatory and clinical documentation requirements. The role focuses on authoring and reviewing high-quality clinical and safety documents in compliance with EU MDR and ISO 14155 standards for medical devices.
This position is ideal for professionals with hands-on experience in medical device clinical evaluation and regulatory writing who are looking to grow within a fast-paced, compliance-driven environment.
Key Responsibilities
Author and review Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Post-Market Clinical Follow-up (PMCF) reports, and Periodic Safety Update Reports (PSURs)
Ensure all documentation aligns with EU MDR regulations and applicable international standards, including ISO 14155
Conduct comprehensive literature searches, clinical data analysis, and scientific interpretation for medical devices
Collaborate closely with regulatory affairs and pharmacovigilance teams to manage documentation timelines and deliverables
Maintain high standards of scientific accuracy, regulatory compliance, and document quality
Support internal audits and regulatory submissions as required
Qualifications & Experience
Education:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or related disciplines
B.Tech / M.Tech in Biomedical, Electronics, or Mechanical Engineering will also be considered
Experience Required:
1–3 years of relevant experience in medical writing for medical devices
Strong working knowledge of EU MDR, clinical evaluation processes, and regulatory documentation
Excellent scientific writing, analytical, and communication skills
Additional Preferences:
Immediate joiners or candidates with a notice period of up to 30 days preferred
Why Join 4C Pharma Solutions
Opportunity to work on diverse global medical device projects
Exposure to experienced regulatory and medical writing professionals
Competitive compensation package of ₹5–8 LPA, based on experience
Supportive, growth-oriented, and quality-driven work culture
Stable full-time, work-from-office role based in Hyderabad
How to Apply
Interested candidates may send their updated resume to:
hr@4cpharma.com
sushmitha.r@4cpharma.com
Subject Line:
Application – Senior Medical Writer (Medical Devices)
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