Job Title: Executive / Manager - Regulatory Affairs (Medical Devices)*

*Company: Shinelife Meditec LLP - Bhiwandi, Maharashtra*

*Experience: 2 - 6 Years in Medical Device*

*Qualification: B.Pharm / M.Pharm / B.E Biomedical / M.Sc*

*Job Description:*

*1. Regulatory Compliance:*

- Responsible for complete regulatory activities for Medical Devices in India (CDSCO, State FDA).

- Preparation and submission of dossiers for Import License, Manufacturing License, MD-14, MD-15, Test License MD-13, MD-17 etc.

- Knowledge of Medical Device Rules, 2017 & its amendments.

*2. Documentation:*

- Preparation, review and compilation of Device Master File (DMF), Plant Master File, and other technical documents.

- Ensure compliance with ISO 13485, ISO 14971, and QMS requirements.

*3. Licensing & Coordination:*

- Liasoning with CDSCO, Notified Bodies,



and consultants for timely approvals.

- Handling SUGAM portal activities.

- Maintaining regulatory licenses and timely renewals.

*4. Product Registration:*

- Support for international registrations - USFDA, EU MDR, ASEAN countries will be added advantage.

- Labeling review as per regulatory requirements.

*5. Other Responsibilities:*

- Support QA/RA for audits, CAPA, and risk management.

- Keep updated with latest regulatory guidelines.

*Required Skills:* Strong knowledge of CDSCO, SUGAM, Medical Device Rules 2017, ISO 13485, Valuable Documentation Practice.

Pay: ₹300,000.00 - ₹360,000.00 per year

Benefits:

- Provident Fund

Work Location: In person

📌 Medical Device regulatory affairs (Kalyan)
🏢 Shinelife Meditech
📍 Kalyan