Job Title: Executive - Regulatory Affairs (RA)

Company: Lars Medicare Pvt. Ltd.

Location: Sonipat, Haryana

Reporting To: Manager - RA / GM - QA / RA

Experience: 3-5 years

Responsibilities

- Manage the preparation and submission of regulatory dossiers for product registrations in domestic and international markets.
- Ensure all product labels, instructions for use (IFU), and promotional materials comply with CDSCO and global regulatory requirements.
- Maintain comprehensive records of manufacturing licenses, import/export permits, and product approvals.
- Coordinate with the R&D; and Production departments to gather technical data for regulatory submissions.
- Monitor changes in international medical device regulations, including EU MDR and USFDA guidelines, to ensure ongoing compliance.
- Facilitate the submission of post-market surveillance (PMS) and vigilance reports to relevant regulatory authorities.
- Maintain the Regulatory Master File and ensure all documentation is current and audit-ready.
- Review change control requests to assess the impact on existing regulatory approvals and licenses.
- Assist in the preparation of technical files for CE marking and other international quality certifications.




- Ensure all documentation adheres to ISO 13485 standards and internal quality management protocols.
- Maintain a database of global registration requirements to support the expansion into new international territories.
- Support the QA department during external audits by providing necessary regulatory documentation and evidence.
- Ensure 100% accuracy in the documentation provided for tender submissions and hospital procurement requirements.

Requirements :

- B.Pharm / M.Pharm / M.Sc or a degree in a relevant life sciences field.
- 3-5 years of dedicated experience in Regulatory Affairs within the medical device or pharmaceutical industry.
- Thorough knowledge of CDSCO Medical Device Rules and international registration processes (CE, ISO).
- Proven experience in preparing technical files, dossiers, and post-market reports.
- Solid organizational skills with the ability to manage multiple regulatory deadlines simultaneously.
- Excellent technical writing and communication skills for interacting with regulatory authorities.

Job Types : Full-time, Permanent

Pay: ₹18,000.00 - ₹25,000.00 per month

Work Location: In person

📌 Regulatory Affairs Officer (Haryana)
🏢 Lars Medicare
📍 Haryana