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Looking to advance your career in Regulatory Affairs Medical Writing for Medical Devices? A promising opportunity is now open at RegTrac for the role of Regulatory Associate โ Medical Writing in Chennai. This role is ideal for professionals with 2โ3 years of experience in EU MDR, clinical evaluation reports (CER), and ISO standards who want to work on global MedTech regulatory projects.
RegTrac is recognized for its expertise in global regulatory affairs, quality systems, and compliance, making this position highly valuable for candidates aiming to build a long-term career in medical device regulatory writing and compliance.
Key Responsibilities โ Regulatory Affairs & Medical Writing
As a Regulatory Associate โ Medical Writing, you will:
- Prepare and support technical files for CE marking and UKCA submissions
- Develop and review Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP)
- Act as a subject matter expert in EU MDR medical writing
- Lead and coordinate medical writing projects across teams
- Ensure compliance with ISO 13485, ISO 14971, and ISO 10993 standards
- Respond to regulatory queries from manufacturers and clients
- Support regulatory audits, inspections, and QMS processes
- Collaborate with cross-functional teams for project execution and documentation
- Assist in proposal writing, regulatory strategy, and client engagement
- Develop training materials and conduct regulatory training sessions
Required Qualifications & Skills
Education:
- Postgraduate degree in Life Sciences / Pharmacy / Biotechnology or related field
Experience:
- 2โ3 years in Regulatory Affairs or Medical Writing (Medical Devices)
Technical Skills:
- Strong knowledge of EU MDR regulations
- Experience in CER/CEP writing
- Familiarity with QMS and ISO standards (13485, 14971, 10993)
- Understanding of CE Marking and UKCA regulatory pathways
Core Competencies:
- Excellent technical writing and communication skills
- Strong analytical and regulatory interpretation abilities
- Ability to manage multiple projects and stakeholders
- Detail-oriented with a compliance-driven mindset
Salary & Benefits
- Estimated Salary: โน4.5 LPA โ โน8 LPA (based on experience)
- Career growth in global regulatory affairs projects
- Exposure to EU MDR and international compliance standards
- Training and development programs
- Supportive and collaborative work environment
- Opportunity to work with global MedTech clients
Why Join RegTrac?
- Specialized focus on Medical Device Regulatory Affairs
- Strong presence in EU and global compliance consulting
- Opportunities for career advancement in medical writing
- Inclusive and growth-driven organizational culture
Job Location
- Chennai, Tamil Nadu, India
- Work Mode: On-site
- Job Type: Full-time
How to Apply
Interested candidates can:
- Apply directly via the job post
- Or send your updated resume to: info@reg-trac.com
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