Regulatory Affairs Specialist

📋 Description

• Support regional regulatory affairs activities by coordinating domestic and international product
• Prepare, compile, and maintain technical documentation and regulatory files required for medical
• Coordinate tender-related submissions and prepare responses to audit findings and regulatory
• Monitor changes in Indian regulations and communicate relevant updates to global regulatory teams
• Collaborate with international regulatory representatives to facilitate submissions and respond to
• Maintain product listings and establishment registrations with the relevant Indian regulatory

🎯 Requirements

• A minimum of 2 years of professional experience in a Class II or Class III medical device
• Demonstrated experience with Indian regulatory affairs requirements within the medical device
• Working knowledge of import and export regulations for IT equipment and the BIS certification
• Strong understanding of regulatory submissions, product registration procedures, and medical device
• Excellent written and verbal communication skills, with the ability to collaborate effectively with
• Strong organizational skills, attention to detail, and the ability to manage multiple regulatory

🎁 Benefits

• Competitive benefits package designed to support employees' health, financial well-being, and
• Healthcare coverage and other employee benefit programs, with specific offerings depending on
• Paid time off to support personal needs and well-being.
• Remote work flexibility, with the opportunity to work from home.
• International collaboration with regional and global regulatory professionals.
• Professional development opportunities in medical device regulations, product compliance, and