RegTrac is a premier healthcare regulatory partner specializing in Global Regulatory Affairs, Quality Systems, and Compliance for Medical Devices, Cosmetics, and Consumer Products. With deep expertise in navigating regulatory frameworks across multiple markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring full regulatory compliance.

Our services include:
✔ Strategic Regulatory Insights
✔ Compliance Mastery (FDA, EU MDR, IMDR, ISO 13485)
✔ Regulatory Submissions (510(k), eSTAR, CE Marking)
✔ Training & Market Research

Join us to be part of a team that drives regulatory excellence in the medical device industry.

Job Description: Regulatory Affairs Associate

We are seeking a highly motivated Regulatory Affairs Associate to join our team in Chennai. This role is critical in ensuring regulatory compliance for medical devices throughout their lifecycle. You will collaborate with R&D, Quality Assurance, and Marketing teams to support product development, submissions, and global market access.

Key Responsibilities:

✅ Prepare and submit regulatory filings (510(k), eSTAR, EU MDR) for medical devices.
✅ Review product labeling, promotional materials, and technical documentation for compliance.
✅ Monitor global regulatory changes and advise internal teams.
✅ Liaise with US FDA and other regulatory bodies for audits and inquiries.
✅ Develop regulatory strategies for new product approvals and post-market surveillance.
✅ Conduct regulatory compliance training for cross-functional teams.
✅ Maintain strong relationships with RegTrac clients.

Required Qualifications:

✔ Master’s degree in Regulatory Affairs, Life Sciences, Biotechnology, or related field.
✔ 2–3 years of experience in regulatory affairs (medical devices, pharma, or biotech).
✔ Strong knowledge of FDA regulations and 510(k) submissions.
✔ Experience with eSTAR (electronic Submission Template and Review).
✔ Excellent communication and analytical skills.

Preferred Qualifications:

✔ Experience with EU MDR, IMDR, or other international regulations.
✔ Proficiency in electronic submission systems (e.g., FDA Gateway, EUDAMED).
✔ Regulatory Affairs Certification (RAC) is a plus.

Why Join RegTrac?

🔹 Work with a global leader in medical device regulatory affairs.
🔹 Collaborative and dynamic work environment.
🔹 Career growth opportunities in regulatory compliance.
🔹 Engage with cutting-edge medical technologies.

How to Apply?

Application Link

If you meet the qualifications and are excited about this opportunity, click “Easy Apply” or send your resume to hr@regtrac.com.

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