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

:

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