Roles & Responsibilities:
• Collaborate with in-country regulatory representatives to develop strategies and prepare submissions for India and APAC markets
• Create, review, and approve product labeling, including Instructions for Use (IFUs), packaging, and other materials for the APAC region
• Represent Regulatory Affairs on cross-functional teams, providing strategic input and technical guidance on regional requirements
• Offer regulatory guidance to the software development team
• Review advertising and promotional materials for compliance with local regulations
• Assess the regulatory impact of design and manufacturing changes and execute necessary actions
• Monitor new and evolving regulations in APAC countries, evaluating impacts on existing registrations and internal procedures
• Provide regulatory support during internal and external audits
• Perform other duties as assigned to support team and company goals
Qualification:
• Bachelor’s degree in a relevant field
• Strong knowledge of India and international regulatory requirements for medical devices, including submission processes, labeling, promotion regulations, quality control, and quality management systems
• Expertise in Medical Device Software, software development lifecycle, IEC 62304 standards, and software classification
Experience:
• Minimum 5–8 years of related experience
• Prior experience with regulatory submissions in India preferred
Skills:
• Excellent technical writing, editing, and analytical skills
• Strong problem-solving, proactive learning, organizational, and communication skills
• Ability to work independently and collaboratively in a cross-functional team environment
About the Organisation:
Dexcom Corporation is a global leader in continuous glucose monitoring (CGM) technology, revolutionizing diabetes management for millions worldwide. With over 25 years of innovation, Dexcom empowers people to take control of their health through advanced biosensing solutions and is expanding its impact in the APAC region, including India, driving meaningful health outcomes through cutting-edge medical device technology.
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