Regulatory Affairs Senior Specialist

Responsibilities

• Support new product registrations and license renewals for medical device and fertility products in India, Sri Lanka, and Nepal.
• Act as the primary regulatory liaison with external consultants, distributors, and local health authorities.
• Prepare, coordinate, and submit regulatory applications to local health authorities and distributors.
• Provide regular updates to the management team on registration and renewal status.
• Collaborate with regional and global teams on regulatory documentation and Regulatory Information Management Systems (RIMS).
• Track and monitor regulatory timelines, escalating risks to minimize delays.
• Coordinate with Quality, Manufacturing, Supply Chain, and Commercial teams to ensure uninterrupted product supply.
• Maintain awareness of local regulatory updates, guidelines, and new regulations.
• Support internal and external regulatory or compliance audits.

Requirements

• 3-5 years of experience in Medical Device Regulatory Affairs.
• Mandatory knowledge of regulatory submission processes in India.
• Bachelor’s degree in a science-related field.

Preferred Qualifications

• Knowledge of GDPMD (Good Distribution Practice for Medical Devices).
• Knowledge of post-market reporting.
• Additional knowledge of the regulatory environments in Sri Lanka and Nepal.

About the Company

CooperSurgical is a global leader in medical devices and fertility products, dedicated to supporting healthcare providers and improving patient outcomes through innovation and compliance.