Medical Writing Specialist

What You Can Expect

Independently authors standard sections of regulatory clinical documents with limited supervision. Executes literature
strategies, execute National Joint Registry (NJR) data analysis, ensures traceability and compliance, and collaborates crossfunctionally
to deliver audit-ready documentation.

Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)

How You'll Create Impact

• Independently authors standard sections of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-
  Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Summary of Safety and Clinical Performance
  (SSCP) documents
• Executes NJR analysis and literature search strategies and documents appraisal outcomes
• Drafts clinical safety and performance summaries and benefit–risk analyses
• Ensures traceability across data sources and regulatory requirements
• Maintains template compliance and audit-ready documentation
• Coordinates with Regulatory, Clinical, and Development partners to finalize drafts
• Supports methodological consistency across product lines
• Participates in internal peer reviews
• Manages timelines for assigned deliverables
• Follows established procedures
• Performs quality control checks for formatting, references, and traceability
• Ability to escalate and resolve compliance or risk concerns

What Makes You Stand Out

• Strong scientific and technical writing skills
• Basic working knowledge of medical device clinical and regulatory documentation
• Ability to execute literature strategies and appraise evidence
• Ability to analyze National Joint Registry (NJR) data
• Understanding of global medical device regulations and post-market obligations
• Strong analytical and data synthesis skills
• Effective cross-functional communication
• Ability to manage multiple documents and deadlines
• High attention to detail and commitment to accuracy Willingness to learn regulatory requirements
• Organizational skills and ability to manage multiple deliverables
• Awareness of audit/inspection readiness and compliance expectations

Your Background

• Responsible for authoring Systematic Literature Searches and Clinical Evaluation Reports (CERs) updates for medical devices under Medical Device Regulation (MDR)
• Bachelor's Degree in Health, Life Sciences or related field and 2 years of relevant experience, or Associate's Degree and
  4 years of relevant experience, or High School Diploma or Equivalent and 6 years of relevant experience
• Preferred: Degree in Health, Life Sciences or related field
• Preferred: 2+ years experience in medical or regulatory writing
• Experience in the medical device industry is required Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Summary of Safety and Clinical Performance (SSCP) documents – some experience required.
• Bachelor’s degree in life sciences, engineering or related fields is preferred.
• Very good English oral and written. Critical thinking and attention to detail

Travel Expectations

Up to 5%