RegTrac, a leading healthcare regulatory consulting company specializing in global regulatory affairs, quality systems, and compliance solutions for medical devices and consumer healthcare products, is hiring a Clinical Evidence & Regulatory Medical Writer in Chennai, Tamil Nadu, India.
This opportunity is ideal for professionals with 2-3 years of experience in medical writing, regulatory affairs, and medical devices who are looking to advance their careers in EU MDR compliance, Clinical Evaluation Reports (CER), CE marking, UKCA submissions, and global regulatory documentation.
The selected candidate will work with international MedTech clients and contribute to regulatory strategy, clinical documentation, quality management systems, and training initiatives.
Job Details
- Position: Clinical Evidence & Regulatory Medical Writer
- 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
- Department: Regulatory Affairs & Clinical Evidence
About RegTrac
RegTrac is a trusted healthcare regulatory partner offering services in:
- Global Regulatory Affairs
- Medical Device Compliance
- Quality Management Systems
- Clinical Evaluation Documentation
- Regulatory Training and Consulting
- Market Access and Compliance Solutions
The company supports MedTech organizations in navigating complex global regulatory requirements while ensuring product compliance and successful market expansion.
Key Responsibilities
Regulatory Affairs & Medical Writing
- Prepare technical files for CE and UKCA submissions.
- Lead Clinical Evaluation Report (CER) and Clinical Evaluation Plan (CEP) preparation and review.
- Provide expert support for EU MDR regulatory documentation projects.
- Manage medical writing activities for client studies and projects.
- Resolve regulatory documentation queries from manufacturers.
- Collaborate with cross-functional teams to gather project requirements.
- Prepare project proposals, effort estimates, and sales presentations.
- Maintain strong client relationships and conduct regular feedback sessions.
- Monitor regulatory changes and implement updated compliance requirements.
- Deliver regulatory solutions aligned with global legislation and guidance.
Quality Management Systems (RA-QMS)
- Author and review regulatory procedures and quality documentation.
- Monitor quality processes in compliance with applicable standards.
- Guide stakeholders on industry regulations and standards.
- Support supplier and customer quality management activities.
- Participate in internal and external audits and inspections.
Training & Knowledge Management
- Develop web-based regulatory training materials.
- Create user guides and educational documentation.
- Conduct in-person and online regulatory training sessions.
- Manage regulatory training strategies and employee learning initiatives.
- Maintain training records and documentation.
Required Skills
Candidates should possess:
- Strong knowledge of EU MDR regulations and clinical evaluation processes.
- Expertise in Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP).
- Understanding of medical device technical documentation requirements.
- Knowledge of ISO standards including:
- ISO 13485
- ISO 10993
- ISO 14971
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Attention to detail and regulatory interpretation skills.
- Ability to manage multiple projects and work collaboratively.
Educational Qualifications
Applicants should have:
- Postgraduate degree in Life Sciences or equivalent qualification.
- 2-3 years of experience in:
- Medical Writing
- Regulatory Affairs
- Medical Device Industry
Why Join RegTrac?
RegTrac offers:
- Career progression opportunities
- Specialized regulatory training programs
- Supportive leadership and mentorship
- Employee recognition and rewards programs
- Exposure to global MedTech clients
- Opportunity to work on EU MDR and international regulatory projects
- Inclusive and collaborative work environment
Who Should Apply?
This role is particularly suitable for:
- Medical Writers in the medical device industry
- Regulatory Affairs professionals
- Clinical Evaluation specialists
- EU MDR documentation experts
- Medical device compliance professionals seeking global exposure
How to Apply
