Please Note - This is a two-year contractual position.

Job Overview:

Support regulatory activities for medical devices in India, including product registration, import licensing, regulatory submissions, labeling compliance, Post approval changes and coordination with internal teams and regulatory authorities.

Key Responsibilities:

CDSCO / Medical Device Regulatory Activities:

- Support preparation and submission of CDSCO applications for medical devices.
- Assist with MD-14, MD-15 and other applicable regulatory applications.
- Maintain regulatory licenses, registrations and approval records.
- Track application status and coordinate responses to CDSCO queries.
- Review product information against applicable Indian medical device regulations.
- Support assessment of new products for CDSCO applicability.
- Support regulatory impact assessments for current and modified products.
- Support implementation of regulatory changes in product labeling.




- Coordinate with QA, Supply Chain, Marketing and other stakeholders for label updates.
- Ensure timely renewal/update of applicable licenses and approvals.

Required Qualifications:

- Bachelor’s degree in pharmacy, Life Sciences, Biomedical Engineering, Biotechnology or a related field.
- 1–3 years of experience in Regulatory Affairs, preferably in medical devices.
- Working knowledge of Indian medical device regulations and CDSCO requirements.
- Ability to manage multiple regulatory activities and timelines.

Preferred Knowledge:

- Medical Devices Rules, 2017
- CDSCO medical device licensing/registration
- Import licensing
- Product labeling requirements
- Basic understanding of ISO 13485 and medical-device QMS

📌 Regulatory Affairs Specialist (Contractual) (Delhi)
🏢 Getinge
📍 Delhi