Senior Regulatory Affairs Specialist – Medical Devices
Location: Bengaluru, India (Flex/Remote)
Job Type: Full-Time, Permanent
About Dexcom
Dexcom (NASDAQ: DXCM) is a global pioneer in continuous glucose monitoring (CGM), transforming diabetes management and improving health outcomes worldwide. Over 25 years, Dexcom has grown from a small company with a bold vision into an industry leader in biosensing technology, delivering life-changing insights to millions of people.
Our mission extends beyond diabetes, aiming to empower people to take control of their health with innovative, actionable solutions. Dexcom’s work culture is dynamic, inclusive, and mission-driven, where employees collaborate across science, engineering, clinical research, regulatory affairs, and technology to deliver high-impact solutions.
Role Overview
The Senior Regulatory Affairs Specialist will support the growth and expansion of Dexcom’s CGM systems across India and other APAC markets. This role will involve regulatory strategy development, submission management, labeling oversight, and cross-functional collaboration, ensuring compliance with local and international medical device regulations.
Key Responsibilities
Develop regulatory strategies and prepare submissions for India and APAC markets.
Review, approve, and provide guidance on product labeling, IFUs, and packaging.
Represent Regulatory Affairs on cross-functional teams, offering strategic input and technical guidance.
Provide regulatory support for software development projects, ensuring compliance with Medical Device Software standards (IEC 62304).
Review advertising and promotional materials to ensure regulatory compliance.
Assess regulatory impact of proposed design or manufacturing changes and execute necessary regulatory actions.
Monitor and interpret new and changing regulations in APAC markets, ensuring internal processes and registrations remain compliant.
Support internal and external audits and other regulatory activities as assigned.
Qualifications & Experience
Essential:
Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field.
Minimum 5–8 years of experience in medical device regulatory affairs.
Knowledge of India and international regulatory requirements, including medical device submissions, labeling, promotion regulations, and quality systems.
Experience with medical device software lifecycle, classification, and regulatory standards.
Strong technical writing, analytical, and communication skills.
Ability to work independently and collaboratively in a cross-functional team environment.
Preferred:
Previous experience with regulatory submissions in India and APAC.
Exposure to regulatory audits and compliance assessments.
Why Join Dexcom
Be part of a global leader in CGM technology driving life-changing health solutions.
Enjoy flexible work arrangements (remote/flex) and international collaboration opportunities.
Access comprehensive benefits, learning programs, and career development opportunities.
Contribute to a mission-driven organization committed to innovation, integrity, and improving patient lives.
Travel: 15–25% (as required)
Dexcom is an equal opportunity employer, promoting diversity, inclusion, and professional growth.
Gujarat :
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