Apply for Regulatory Associate Medical Writing Job at RegTrac Chennai. Check eligibility, salary, experience, and application process details now.
Introduction
If you are aiming to build a strong career in medical device regulatory affairs, this opportunity could be the right step forward. The Regulatory Associate Medical Writing Job at RegTrac offers hands-on exposure to global compliance standards and EU MDR requirements. This role is particularly suitable for candidates with prior experience in medical writing and regulatory documentation. Professionals looking to work on international MedTech projects will find this position highly rewarding.
Job Overview
| Particulars | Details |
|---|---|
| Job Title | Regulatory Associate – Medical Writing |
| Company Name | RegTrac |
| Location | Chennai, Tamil Nadu |
| Employment Type | Full-time |
| Department | Regulatory Affairs / Medical Writing |
| Experience Required | 2–3 Years |
| Education | Master’s in Life Sciences / Pharmacy / Biotechnology |
| Salary | ₹4.5 LPA – ₹8 LPA |
Company Overview
RegTrac is a well-established organization specializing in regulatory affairs, quality compliance, and medical device consulting services. The company supports global clients in navigating complex regulatory frameworks such as EU MDR and ISO standards. With a strong reputation in MedTech consulting, RegTrac provides professionals with opportunities to work on international projects and enhance their expertise in regulatory documentation and compliance systems.
Job Location & Employment Type
- Location: Chennai, Tamil Nadu, India
- Work Mode: On-site
- Job Type: Full-time
This role requires candidates to work from the Chennai office, collaborating closely with cross-functional teams on global regulatory assignments.
Open Positions / Department Details
- Department: Regulatory Affairs – Medical Writing
- Role Focus:
- Medical device documentation
- Clinical evaluation writing
- EU MDR compliance projects
Key Roles & Responsibilities
As a Regulatory Associate in Medical Writing, your responsibilities will include:
- Preparing and compiling technical documentation for CE marking and UKCA submissions
- Writing and reviewing Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP)
- Interpreting and applying EU MDR guidelines in documentation
- Coordinating medical writing projects across internal teams
- Ensuring adherence to ISO standards such as 13485, 14971, and 10993
- Responding to regulatory queries from clients and manufacturers
- Supporting audits, inspections, and Quality Management System (QMS) processes
- Collaborating with regulatory, clinical, and quality teams
- Assisting in regulatory strategy development and proposal creation
- Designing and delivering training sessions on regulatory topics
Eligibility Criteria
Education
- Master’s degree in:
- Life Sciences
- Pharmacy
- Biotechnology
- Or any related discipline
Experience
- 2–3 years of experience in:
- Regulatory Affairs
- Medical Writing (Medical Devices preferred)
Skills Required
- Strong knowledge of EU MDR regulations
- Experience in CER and CEP documentation
- Understanding of ISO standards (13485, 14971, 10993)
- Familiarity with CE marking and UKCA processes
- Excellent technical writing and communication skills
- Strong analytical and problem-solving ability
- Ability to manage multiple projects simultaneously
- Attention to detail with a compliance-focused mindset
Salary & Benefits
- Estimated Salary: ₹4.5 LPA – ₹8 LPA
- Exposure to global regulatory frameworks
- Opportunity to work on EU MDR projects
- Continuous learning and professional development programs
- Collaborative and supportive work culture
- Career growth in medical device regulatory writing
- Interaction with international MedTech clients
Selection Process
The hiring process typically includes:
- Application screening
- Technical/functional interview
- Final HR discussion
Candidates with strong regulatory writing experience and EU MDR knowledge will have an advantage.
How to Apply
Interested candidates can apply using the following methods:
- Submit application through the official job posting
- Or email your updated resume to: info@reg-trac.com
Important Dates
- Job Posted On: April 3, 2026
- No last date specified – early application is recommended
Why Apply for This Job?
This opportunity stands out for professionals aiming to specialize in medical device regulatory writing. Working with RegTrac allows you to gain direct exposure to international compliance standards like EU MDR and ISO frameworks. The role not only strengthens your technical writing skills but also enhances your understanding of global regulatory pathways.
Additionally, the company’s involvement in international projects ensures long-term career growth, making it an excellent choice for candidates who want to build expertise in regulatory affairs and medical writing.
FAQs
1. What is the focus of the Regulatory Associate Medical Writing Job at RegTrac?
The role focuses on medical device regulatory documentation, including CER writing, EU MDR compliance, and technical file preparation.
2. What salary can candidates expect?
The salary ranges between ₹4.5 LPA to ₹8 LPA depending on experience and skill level.
3. Is prior medical writing experience mandatory?
Yes, candidates should have 2–3 years of experience in regulatory affairs or medical writing, preferably in medical devices.
4. Where is the job located?
The position is based in Chennai and requires on-site work.
5. How can I apply for this job?
You can apply online or send your resume directly to the provided email ID.
Conclusion
The Regulatory Associate Medical Writing Job at RegTrac is a valuable opportunity for professionals seeking growth in the medical device regulatory domain. With competitive salary, global exposure, and career advancement opportunities, this role is ideal for candidates passionate about regulatory compliance and medical writing. Interested applicants should apply promptly to secure their chance.
Disclaimer
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