Senior Regulatory Affairs Specialist

About the role

The Senior Regulatory Affairs Specialist will support new product registrations and license renewals for medical device and fertility products across India, Sri Lanka, and Nepal. This role ensures compliance with local regulatory requirements and acts as the primary liaison with consultants, distributors, and health authorities.

Key responsibilities

• Prepare, coordinate, and submit regulatory applications to local health authorities and distributors.
• Maintain and renew product registrations in line with local regulations.
• Provide regular status updates to management and propose action plans for any delays.
• Collaborate with regional and global teams on regulatory documentation and RIMS.
• Develop regulatory strategies for new products, product changes, and market expansions.
• Track regulatory timelines, escalating risks to minimize delays.
• Coordinate with Quality, Manufacturing, Supply Chain, and Commercial teams to ensure uninterrupted product supply.
• Stay informed on regulatory updates, guidelines, and new regulations in the assigned countries.
• Establish relationships with local medical device industry associations and participate in policy discussions.
• Support internal and external regulatory audits as required.

Required profile

• 3‑5 years of experience in Medical Device Regulatory Affairs.
• Bachelor’s degree in a science‑related field.
• Knowledge of regulatory submission processes in India; familiarity with GDPMD and post‑market reporting is a plus.
• Awareness of regulatory environments in Sri Lanka and Nepal is advantageous.
• Ability to travel up to 5% of the time.