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 recent 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 (India)
🏢 Getinge
📍 India