RegTrac, a leading healthcare regulatory consulting company, is hiring Regulatory Affairs & Medical Writing Specialists for its Chennai office. This opportunity is ideal for professionals with 2-3 years of experience in medical device regulatory affairs, medical writing, EU MDR compliance, and CE/UKCA submissions.
The position offers exposure to global MedTech projects, clinical evaluation reports, quality management systems, and international regulatory standards. Candidates seeking career growth in medical device regulatory affairs jobs in India can apply for this on-site opportunity in Chennai.
About RegTrac
RegTrac is a healthcare regulatory partner specializing in:
- Global Regulatory Affairs
- Quality Systems Management
- Medical Device Compliance
- Cosmetics and Consumer Product Regulations
- Regulatory Training and Consulting Services
The company supports MedTech organizations in achieving global market access while maintaining compliance with international regulatory requirements.
Job Details
Position: Regulatory Affairs & Medical Writing Specialist
Company: RegTrac
Location: Chennai, Tamil Nadu, India
Job Type: Full-Time
Work Mode: On-site
Experience Required: 2-3 Years
Industry: Medical Devices, Regulatory Affairs, Medical Writing
Key Responsibilities
Regulatory Affairs
- Prepare technical files for CE and UKCA submissions.
- Support European Medical Device Regulation (EU MDR) projects.
- Lead clinical and medical writing projects for MedTech clients.
- Prepare, review, and approve Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP).
- Coordinate medical writing activities across departments.
- Resolve regulatory documentation queries from manufacturers.
- Support proposal preparation and requirement analysis for new business opportunities.
- Ensure all client documentation complies with relevant legislation and guidance.
- Build and maintain strong client relationships.
- Monitor regulatory changes and communicate updates internally.
- Provide estimates and solutions for regulatory projects.
- Work cross-functionally to gather project requirements.
Quality Management System (RA-QMS)
- Author and review quality procedures.
- Monitor quality processes and approved QMS requirements.
- Provide guidance on regulatory standards and industry regulations.
- Support internal and external audits.
- Collaborate with QA teams on supplier and customer audits.
Training Responsibilities
- Develop web-based regulatory training materials.
- Create user guides and supporting documentation.
- Conduct regulatory training sessions.
- Design customized training programs for clients.
- Support organizational regulatory training strategies.
- Ensure training documentation and records are maintained.
Required Skills
Candidates should possess:
- Excellent written and verbal communication skills
- Strong analytical and problem-solving abilities
- Attention to detail and interpretation of regulations
- Project management capabilities
- Self-motivation and willingness to learn
- Team collaboration skills
- Process-driven approach with effective solutioning mindset
Technical Knowledge Required
Applicants should have knowledge of:
- European Medical Device Regulation (EU MDR)
- CE Marking and UKCA Requirements
- Clinical Evaluation Reports (CER)
- Clinical Evaluation Plans (CEP)
- ISO 13485
- ISO 10993
- ISO 14971
- Medical Device Quality Management Systems
- Regulatory Documentation and Technical Files
- Medical Writing for Medical Devices
Educational Qualifications
Minimum qualification:
- Life Sciences Postgraduate Degree or equivalent qualification
Preferred educational backgrounds include:
- M.Pharm
- Pharm.D
- M.Sc Life Sciences
- Biomedical Sciences
- Biotechnology
- Medical Devices and Regulatory Sciences
Experience Requirement
- Minimum 2-3 years of experience in:
- Medical Writing
- Regulatory Affairs
- Medical Device Industry
- Clinical Evaluation Documentation
- Medical Device Compliance
Why Join RegTrac?
RegTrac offers:
- Career progression opportunities
- Specialized regulatory training
- Supportive leadership and management
- Exposure to global MedTech projects
- Recognition and rewards programs
- Collaborative and inclusive work culture
- Opportunity to work with international regulatory standards
How to Apply
