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Expect scenarios on CGM labeling, post-market surveillance, recall communications, and Asia-Pacific registration timelines. Prepare examples of risk assessments and cross-site regulatory alignment.
Strong fit if you have medical-device RA leadership, diabetes-tech or implantables exposure, and comfort operating from Singapore for a global DXCM organization.
As Senior Manager, Regulatory Affairs for Dexcom in Singapore, you would steer CGM submissions and variations for regional markets, align labeling and quality evidence with manufacturing sites, and coordinate cross-functional responses to safety, recall, and distributor-control issues.
Strengthen device regulation, CAPA/quality systems, and project leadership. Free options: Saylor Academy — Business & Management courses (free); Google Project Management — Skillshop / free intro resources (free).
Continuous glucose monitoring systems used in diabetes management, sold internationally under ticker DXCM.
No. The listing is based in Singapore (remote flag is 0).
Saylor Business & Management and Google Project Management intro resources are listed as free in the cert data.
Website: dexcom.com
Dexcom, Inc. is an American multinational healthcare company that develops, manufactures, produces and distributes a line of continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with global headquarters and R&D center in San Diego, California, U.S., and manufacturing facilities in Mesa, Arizona, U.S.; Batu Kawan, Malaysia; and Athenry, County Galway, Ireland.
Public cache only — not an employee review.
Sr Manager Regulatory Affairs at DexCom - Singapore Role Overview The Sr Manager of Regulatory Affairs at DexCom in Singapore will play a pivotal role in ensuring compliance with regulatory requirements for our innovative continuous glucose monitoring (CGM) products. This position requires a strategic thinker who can navigate complex regulatory landscapes and drive regulatory strategies that support the company's global expansion. Core Duties Lead the development, implementation, and maintenance of regulatory strategies to ensure compliance with international and local regulations. Collaborate with cross-functional teams including R&D, Quality Assurance, and Marketing to ensure product safety and efficacy data is accurately documented and submitted for regulatory approval. Manage and coordinate external regulatory agencies and consultants to facilitate the submission process and address any regulatory issues promptly. Stay updated on regulatory trends and changes in legislation that may impact DexCom's products or operations. What We're Looking For A minimum of 10 years of experience in a senior regulatory affairs role, preferably within the medical device industry. Demonstrated success in leading cross-functional teams and managing external stakeholders. Strong knowledge of global regulatory requirements for medical devices, particularly those related to CGM products. Excellent communication and negotiation skills to effectively represent DexCom's interests with regulatory bodies. About DexCom Dexcom Corporation (NASDAQ: DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Founded on the belief that information drives better health outcomes, DexCom has been at the forefront of diabetes management for over 25 years. Our mission is to forever change how diabetes is managed by unlocking critical insights through our innovative CGM solutions. Ready to Apply? To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.
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