Regulatory Affairs Specialist (Contractual)

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 new 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