This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Regulatory Affairs Specialist based in India.

The Regulatory Affairs Specialist will play a key role in securing regulatory approvals for innovative medical devices in the Indian market. This position offers the opportunity to work at the intersection of medical technology, regulatory compliance, and product innovation. You will collaborate with regional and global regulatory teams to support product registrations, submissions, and regulatory documentation. The role involves interpreting local regulatory requirements and assessing their impact on product development and commercialization. You will contribute to maintaining compliance with applicable Indian medical device regulations and import/export requirements. Working closely with cross-functional stakeholders, you will help ensure that regulatory processes are accurate, efficient, and aligned with business objectives.



This is an excellent opportunity for a regulatory professional seeking to deepen their expertise in a energetic, internationally connected healthcare technology environment.

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Accountabilities

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Support regional regulatory affairs activities by coordinating domestic and international product filings, registrations, and regulatory submissions.

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Prepare, compile, and maintain technical documentation and regulatory files required for medical device approvals.

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Coordinate tender-related submissions and prepare responses to audit findings and regulatory inquiries.

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Monitor changes in Indian regulations and communicate relevant updates to global regulatory teams, including assessments of their potential impact on products and business operations.

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Collaborate with international regulatory representatives to facilitate submissions and respond to requests from health authorities.

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Maintain product listings and establishment registrations with the relevant I

📌 Regulatory Affairs Specialist (India)
🏢 Jobgether
📍 India