Chetan Meditech is hiring a Regulatory Affairs Coordinator in Sanand, Gujarat for professionals with experience in medical device regulatory affairs, dossier preparation, and international product registration.
This opportunity is ideal for B.Pharm or M.Pharm graduates who want to build a career in medical device regulatory affairs, global regulatory submissions, and compliance management.
The role involves supporting regulatory filings, dossier compilation, labeling compliance, and coordination with internal departments to ensure product approval across multiple international markets including Africa, LATAM, APAC, EMEA, and MEA regions.
Professionals with knowledge of EU MDR, FDA 21 CFR, CDSCO guidelines, ISO 13485, ISO 14971, and GSPR requirements will find this role highly relevant for career growth in the medical device regulatory domain.
Job Details
Position: Regulatory Affairs Coordinator
Company: Chetan Meditech
Location: Sanand, Gujarat, India
Industry: Medical Devices
Employment Type: Full Time
Experience: 1โ3 Years
Salary: โน5.5 โ โน6 LPA (Approx.)
Key Responsibilities
The Regulatory Affairs Coordinator will support global regulatory compliance and product registration activities.
Regulatory Submissions
- Assist in medical device dossier preparation and compilation
- Support regulatory submissions to authorities across APAC, EMEA, LATAM, MEA, and African markets
- Ensure compliance with country-specific regulatory guidelines
Regulatory Documentation
- Review technical documentation for regulatory filings
- Maintain records of regulatory submissions, approvals, and authority communications
- Conduct basic research on regulatory guideline updates
Cross-Functional Coordination
- Coordinate with Production, QA, QC, and Clinical teams
- Work with the Artwork team to ensure regulatory compliant labeling and packaging
- Support responses to regulatory queries and deficiencies
Compliance Activities
- Support change control and CAPA processes
- Assist in new product registration and renewals
- Ensure regulatory compliance across international markets
Required Qualifications
Candidates applying for this Regulatory Affairs Coordinator job in medical devices should meet the following criteria:
Education
- B.Pharm or M.Pharm
- MS in Medical Device Regulatory Affairs (preferred)
Experience
- 1โ3 years experience in regulatory affairs
- Experience in medical device regulatory documentation
Required Skills
Candidates should have strong knowledge of global medical device regulatory frameworks including:
- GSPR (General Safety and Performance Requirements)
- EU MDR 2017
- FDA 21 CFR
- CDSCO medical device regulations
- ICH Guidelines
- ISO 13485
- ISO 14971
- ISO 20417
- ISO 11607
- ISO 15223
Additional requirements:
- Experience in medical device dossier preparation
- Understanding of international product registration
- Proficiency in Microsoft Office and SharePoint
- Strong written and verbal communication skills
Why Join Chetan Meditech?
Working with Chetan Meditech offers exposure to global medical device regulatory affairs operations, including:
- International regulatory submissions
- Medical device product registrations
- Global regulatory compliance frameworks
- Cross-functional collaboration with QA, production, and clinical teams
This role is ideal for professionals aiming to build a career in medical device regulatory affairs and global compliance management.
How to Apply
