Regulatory Medical Writer
Regulatory Medical Writer
Zimmer Biomet
Job description
Are you looking for a role in clinical documentation, scientific evidence, regulatory compliance and medical device safety? Learn more about Regulatory Medical Writer job with Zimmer Biomet in Bengaluru, India.
Company Description
Zimmer Biomet is a global medical technology leader that is driven to make healthcare better. It develops and manufactures orthopedic implants, surgical technology and related healthcare solutions. The company is dedicated to innovation, clinical evidence, product safety and collaboration to advance medical care and improve patients’ quality of life around the world.
Job Summary
The Regulatory Medical Writer is responsible for leading clinical and regulatory documentation for medical devices. The scientific writer responsibilities include writing Clinical Evaluation Reports, Summary of Safety and Clinical Performance documents and other clinical post-market reports. The medical writer specialist studies scientific literature, assesses clinical and safety data, makes benefit-risk assessments, responds to regulatory requests, reads documents, supervises junior writers and promotes compliance and continuous improvement.
Key Responsibilities
Guide the creation of Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCP) documentation.
Write Clinical Evaluation Plans (CEPs), Post-Market Surveillance (PMS) reports and Post-Market Clinical Follow-up (PMCF) documentation.
Design and perform literature searches, systematic literature reviews, evidence appraisals and syntheses.
Build strong benefit-risk assessments to assist clinical evaluation and regulatory choices.
Independently respond to Notified Bodies and regulatory bodies inquiries connected to clinical documentation.
Conduct expert peer review for scientific accuracy, consistency and compliance.
Mentor and guide junior medical writers on documentation standards.
Partner with Clinical, Regulatory and Development teams on evidence strategy.
Assist audits and inspections; Improve writing templates, processes and documentation standards.
Educational Qualification
Bachelor’s degree in Health Sciences, Life Sciences or comparable discipline with minimum four years of related experience or,
An associate’s degree and six years of related experience or,
A high school diploma or equivalent and eight years of related experience.
At least 4 years of experience in medical or regulatory writing.
Skills Required
Advanced scientific and regulatory writing skills.
Knowledge of Clinical Evaluation Plans, Clinical Evaluation Reports, PMS, PMCF and SSCP documents.
Strong skills in literature review, evidence appraisal and evidence synthesis.
Ability to understand clinical and safety data, and conduct benefit-risk assessments.
Understanding of clinical documentation and regulatory standards for medical devices.
Analytical thinking, problem solving and attention to detail.
Excellent written and verbal English communication.
Mentor colleagues, examine technical documentation, and collaborate with cross-functional teams.
Commitment to quality improvement, regulatory compliance and audit readiness.
Salary Structure
The average salary of a Medical Writer in Bengaluru is between ₹6 Lakhs to ₹8 Lakhs per annum.
Career Development
The Regulatory Medical Writer provides possibilities to develop expertise in clinical and regulatory medical writing, advanced evidence evaluation, mentoring of junior colleagues and collaboration with healthcare teams around the world. Experience in medical device documentation and regulatory compliance can facilitate advancement to senior medical writing, medical affairs and regulatory affairs jobs.
How to Apply
Visit our job portal and search for the role of Regulatory Medical Writer.
Review eligibility criteria and job details.
Upload your resume.
Complete the form and submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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