Regulatory Affairs Senior Specialist

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 regulatoryrelated communications submissions responses and followups. 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.

• Provide regulatory input and guidance for assigned countries on regulatoryrelated 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.

Travel:

5 %

Knowledge Skills and Abilities:

• 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

Work Environment:

• Office based

Experience:

• 3 5 years experience in Medical Device Industry

Education:

• Bachelors degree in any Science related field