Medical Affairs Manager, Product Development - Metabolic Health

DexCom, Inc.

Job Overview

Location

Remote - United States

Job Type

Full-time

Full Job Description

📋 Description

• Serve as the primary Medical Affairs representative on cross-functional product development teams focused on metabolic health, including over-the-counter continuous glucose monitoring (CGM) and related consumer health solutions.
• Contribute to and execute Medical Affairs strategy across the full product lifecycle—from concept development through post-market surveillance—for metabolic health products targeting health & wellness, prediabetes, and type 2 diabetes.
• Provide subject matter expertise in metabolic health, including behavior change, lifestyle interventions, and clinical evidence generation, to guide product design, clinical strategy, and claims planning.
• Conduct comprehensive benefit-risk assessments and develop risk mitigation strategies to ensure product safety and clinical relevance in alignment with regulatory expectations.
• Lead hazard and harm identification, risk analysis, and documentation activities in compliance with applicable quality and regulatory standards for medical devices and digital health products.
• Inform and oversee scientific literature reviews and evidence generation plans to support product development decisions and regulatory submissions.
• Engage with key opinion leaders (KOLs) in metabolic health, including identification, relationship building, and collaboration to advance scientific understanding and product adoption.
• Ensure all product development activities adhere to applicable regulatory frameworks, including FDA guidelines and international quality standards for medical devices and digital health.
• Represent Medical Affairs in internal and external forums, including scientific meetings, regulatory interactions, and cross-departmental strategy sessions.
• Collaborate closely with Product Management, R&D, Clinical Affairs, and Regulatory teams to align product development with unmet clinical needs and user-centric design principles.
• Translate scientific evidence and clinical insights into actionable product requirements that drive meaningful health outcomes for consumers.
• Support lifecycle management activities, including post-market surveillance, real-world evidence collection, and product improvements based on clinical feedback.
• Maintain awareness of evolving trends in metabolic health, consumer health technology, and digital therapeutics to inform strategic product development priorities.
• Operate effectively in a dynamic, fast-paced environment with evolving priorities and cross-functional dependencies.
• Travel up to 5–15% to support team meetings, KOL engagements, and industry events.

🎯 Requirements

• Active license as a Registered Dietitian (preferred); other licensed healthcare professionals with relevant metabolic health expertise will be considered
• Minimum of 8–12 years of related experience in Medical Affairs, with a Bachelor’s degree; graduate degree with 4 years of experience is desirable
• Proven experience in Medical Affairs within medical devices, digital health, or consumer health environments, specifically in product development and risk management
• Demonstrated experience across the full product lifecycle, from concept through post-market surveillance
• Expertise in metabolic health, including prediabetes, type 2 diabetes, behavior change, and lifestyle interventions
• Proven ability to interpret and apply scientific evidence to product development decisions

🏖️ Benefits

• Access to life-changing CGM technology and participation in Dexcom’s global innovation mission
• Comprehensive benefits program
• Global growth opportunities
• Career development through in-house learning programs and qualified tuition reimbursement
• Opportunity to work in an innovative, industry-leading organization committed to employee and community impact
• Flex workplace option available for those within commuting distance of a Dexcom site

Skills & Technologies

Remote

Degree Required

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DexCom, Inc.

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About DexCom, Inc.

DexCom, Inc. develops, manufactures, and distributes continuous glucose monitoring (CGM) systems for diabetes management. Its sensors, transmitters, and software provide real-time glucose data to patients and healthcare providers. The company serves insulin-intensive diabetes populations worldwide.

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