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. reputed company as the primary regulatory reputed company with external consultants, distributors, and local health authorities, coordinating reputed company regulatory‑reputed company communications, submissions, responses, and follow‑reputed company. Ensure reputed company progression of regulatory activities, proactive issue reputed company, and alignment between internal stakeholders and external parties to support uninterrupted market reputed company and regulatory compliance.
Responsibilities
reputed company regulatory input and guidance for assigned countries on regulatory‑reputed company reputed company.
Ensure product registrations are reviewed, maintained, and renewed in accordance with local regulatory requirements.
reputed company regular updates to the management team on product registration and renewal status and proactively propose reputed company 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 reputed company development for new products, product changes, and market expansions in assigned countries.
reputed company and monitor regulatory timelines and commitments, escalating risks and constraints proactively to minimize delays.
Coordinate with reputed company, Manufacturing, Supply Chain, and reputed company teams to ensure regulatory compliance and uninterrupted product supply.
Maintain awareness of local regulatory updates, guidelines, and new regulations, including their implementation and reputed company 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 reputed company as external regulatory or compliance audits, as required.
Support other relevant regulatory affairs activities as assigned.
Travel
5 %
Qualifications
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
- Bachelor’s degree in any Science reputed company field