Regional Regulatory Affairs Specialist

We are looking for a Regulatory Affairs Associate – India & ASEAN to join our team. In this role, you will support regulatory activities across India and ASEAN, including product registrations, license maintenance, regulatory submissions, and post-approval activities. This role works closely with global and regional Regulatory Affairs teams, distributors, local representatives, and other cross-functional stakeholders to ensure regulatory requirements are understood and effectively managed.

The successful candidate will coordinate regulatory submissions and documentation, track regulatory timelines and approvals, support responses to regulatory authority queries, and maintain accurate regulatory records and databases. The role will also support post-market regulatory activities, including incident reporting, field safety corrective actions, recalls, periodic or other regulatory reports, and related regulatory authority submissions, in collaboration with Quality, Supply Chain, distributors, and local representatives.

The role will contribute to regulatory intelligence and compliance monitoring, including tracking changes in regulations and guidance across India and ASEAN and assessing their potential impact on products and business activities. Working collaboratively across functions, this individual will help ensure timely regulatory support for product launches, market access, post-market compliance, and ongoing commercialization across the region.

• →Support preparation, coordination, and submission of product registration, license applications, renewals, variations, and other regulatory submissions across India and ASEAN.
• →Support communications and interactions with regulatory authorities, local representatives, distributors, and other regulatory partners to facilitate timely submission reviews and approvals.
• →Prepare, review, and maintain accurate regulatory documents, submission packages, licenses, certificates, and regulatory databases in accordance with applicable requirements.
• →Monitor and manage ongoing regulatory obligations, including license renewals, post-approval changes, product lifecycle activities, and other market-specific requirements.
• →Coordinate post-market regulatory activities, including adverse event and incident reporting, field safety corrective actions, recalls, and other reportable events, ensuring country-specific reporting requirements and timelines are met in collaboration with Quality, Medical, distributors, and local representatives.
• →Monitor regulatory developments, guidance, and changes across India and ASEAN, assess potential impact on the business and product portfolio, and communicate relevant updates to stakeholders.
• →Review and approve ad/promo materials according to country regulatory requirements.
• →Work closely with Global and Regional Regulatory Affairs, Quality, Medical, Clinical, Supply Chain, Commercial, and other functions to support regulatory strategies and business objectives.
• →Provide regulatory support for new product launches, market expansion, product introductions, and ongoing commercialization activities, including coordination of regulatory requirements and readiness.
• →Maintain regulatory trackers and dashboards, monitor submission and approval timelines, identify potential risks or delays, and contribute to improving regulatory processes and ways of working across India and ASEAN.

• Bachelor’s degree in Biomedical Sciences or a related field.
• 3–5 years of Regulatory Affairs experience in the medical device industry, with direct experience in product registration and application of regulatory requirements and standards in India and/or ASEAN.
• Working knowledge of medical device regulatory requirements in India and/or ASEAN markets, with the ability to interpret and apply country-specific regulations and requirements.
• Experience coordinating regulatory submissions and product registrations, including new registrations, license renewals, and post-approval changes.
• Knowledge of international regulations and standards applicable to Class II and Class III (or equivalent) medical devices, preferably implantable medical devices.
• Understanding of post-market regulatory requirements, including adverse event/incident reporting, field safety corrective actions, recalls, and other applicable regulatory reporting obligations.
• Strong analytical and problem-solving skills, with the ability to interpret regulatory requirements, assess regulatory risks and issues, synthesize diverse information, and develop practical solutions.
• Strong communication and stakeholder management skills, with the ability to clearly communicate regulatory requirements, risks, timelines, and issues to technical and non-technical stakeholders.
• Strong attention to detail and organizational skills, with the ability to manage multiple regulatory activities, prioritize effectively, meet deadlines, and adapt to shifting business priorities.
• Ability to work independently with limited supervision, while demonstrating sound judgment, proactive follow-through, and the ability to collaborate effectively with cross-functional and regional teams.