Scientist - Medical Writing

Why This Role Matters

Medical writing in the medical device industry directly impacts regulatory approvals, market access, and patient safety. Clinical Evaluation Reports (CERs) and Safety Surveillance Reports (SSRs) are essential regulatory documents that demonstrate clinical performance and ongoing safety monitoring of medical devices.
This role ensures regulatory documentation is scientifically accurate, compliant with global standards, and aligned with quality systems. By supporting CER and SSR processes, the Scientist – Medical Writing strengthens compliance readiness and contributes to maintaining a strong regulatory profile.

Job Description

The Scientist – Medical Writing supports and executes Clinical Evaluation Report (CER) and Safety Surveillance Report (SSR) activities across assigned therapeutic areas within the medical device business. The role requires expertise in scientific writing, regulatory interpretation, and cross-functional collaboration.

Key Features of the Role

• End-to-end involvement in Clinical Evaluation Plans (CEPs), CERs, and SSRs
• Exposure to global medical device regulatory requirements
• Direct interaction with cross-functional stakeholders
• Participation in audits and regulatory inspections
• Opportunity to contribute to global process improvement initiatives

Responsibilities

• Prepare Clinical Evaluation Plans (CEPs) in accordance with regulatory and internal procedures
• Develop compliant Clinical Evaluation Reports (CERs) aligned with client and regulatory guidelines
• Create and maintain Safety Surveillance Reports (SSRs) ensuring scientific accuracy and compliance
• Link CER and SSR documentation with Quality Systems and regulatory documents such as Risk Management and PMS files
• Develop and manage communication models for CER/SSR coordination with business partners
• Assist in planning schedules to ensure timely completion of documentation deliverables
• Participate in workshops and initiatives to improve global CER/SSR processes
• Stay updated on regulatory requirements and industry best practices
• Support and act as SME during audits and inspections related to CER/SSR processes
• Collaborate with Medical Directors, Post Market Surveillance, R&D, Design Quality, and Regulatory Affairs teams

Required Qualifications

• Strong scientific and regulatory writing skills
• In-depth understanding of medical device clinical evaluation requirements
• Knowledge of regulatory compliance and post-market safety processes
• Ability to manage multiple documentation timelines independently
• Strong analytical thinking and attention to detail

Educational Requirements

• Graduate or Post-graduate degree in Life Sciences

Experience and Skills

• Minimum 3 years of experience in Medical, Technical, or Scientific Writing
• Experience within the medical device industry is mandatory
• Hands-on experience in Clinical Evaluation Report regulatory requirements and document preparation
• Knowledge of quality regulatory compliance frameworks
• Understanding of complaint handling, adverse event reporting, and risk management processes
• Familiarity with common biostatistical methods
• Regulatory or Notified Body audit experience preferred
• Strong written and verbal communication skills
• Organized and methodical working style

Salary Insights

• Compensation depends on experience level and regulatory expertise
• Candidates with strong CER experience and audit exposure typically fall within mid-to-senior salary brackets in Bengaluru

Company Overview

ClinChoice is a global clinical research and consulting organization supporting pharmaceutical, medical device, and consumer care innovators. Established in 1995, the company provides expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology.
With a strong global presence, ClinChoice supports clients in maintaining regulatory compliance locally and internationally while delivering high-quality, data-driven solutions.

FAQs

• Is medical device experience mandatory?
Yes, experience in medical device CER documentation is required.

• Will this role involve audits?
Yes, participation in audits and inspections may be required.

• Does this role require statistical knowledge?
Basic understanding of biostatistical methods is preferred.

Application Tips

• Highlight specific CER and SSR projects handled
• Demonstrate understanding of regulatory frameworks and risk management integration
• Mention audit participation experience
• Emphasize ability to manage tight documentation timelines
• Showcase strong analytical and regulatory writing achievements