Senior Regulatory Affairs Specialist at hcjy in Gurgaon, Haryana, India

Job description

• Support new product registrations and license renewals for medical device and fertility products in India, Sri Lanka, and Nepal, ensuring compliance with applicable local regulatory requirements. Act as the primary regulatory liaison with external consultants, distributors, and local health authorities, coordinating all regulatory‑related communications, submissions, responses, and follow‑ups. Ensure timely progression of regulatory activities, proactive issue resolution, and alignment between internal stakeholders and external parties to support uninterrupted market access and regulatory compliance.

Responsibilities

• Provide regulatory input and guidance for assigned countries on regulatory‑related matters.
• Ensure product registrations are reviewed, maintained, and renewed in accordance with local regulatory requirements.
• Provide regular updates to the management team on product registration and renewal status and proactively propose action plans in the event of delays.
• Collaborate closely with regional and global teams on regulatory documentation and Regulatory Information Management Systems (RIMS).
• Prepare, coordinate, and submit regulatory applications to local health authorities and/or distributors, as appropriate.
• Support regulatory strategy development for new products, product changes, and market expansions in assigned countries.
• Track and monitor regulatory timelines and commitments, escalating risks and constraints proactively to minimize delays.
• Coordinate with Quality, Manufacturing, Supply Chain, and Commercial teams to ensure regulatory compliance and uninterrupted product supply.
• Maintain awareness of local regulatory updates, guidelines, and new regulations, including their implementation and impact on the business.
• Establish and maintain relationships with local medical device industry associations and participate in discussions on regulatory policies, where applicable.
• Support internal regulatory audits as well as external regulatory or compliance audits, as required.
• Support other relevant regulatory affairs activities as assigned.

Requirements

• 3 -5 years of experience in Medical Device Regulatory Affairs
• Knowledge on GDPMD would be an advantage
• Knowledge on post market reporting would be an advantage
• Mandatory knowledge for regulatory submission in India
• Additional knowledge of regulatory environment in Sri Lanka and Nepal would be an advantage
• 3 – 5 years experience in Medical Device Industry
• Bachelor’s degree in any Science related field

Skills

Required

• Regulatory submission in India
• Medical Device Regulatory Affairs
• Regulatory compliance

Preferred

• Knowledge on GDPMD
• Knowledge on post market reporting