Sr Regulatory Affairs Specialist

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later having pioneered an industry. And were just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized actionable insights aimed at solving important health challenges. To continue what weve started: Improving human health.

We are driven by thousands of ambitious passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening serving with integrity thinking big and being dependable. Weve already changed millions of lives and were ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve come a long way from our small company days our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later having pioneered an industry. And were just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized actionable insights aimed at solving important health challenges. To continue what weve started: Improving human health.

We are driven by thousands of ambitious passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening serving with integrity thinking big and being dependable. Weve already changed millions of lives and were ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve come a long way from our small company days our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Meet the team:

The Senior Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to spearhead RA efforts for Dexcoms Artificial Intelligence-enabled software products and features. The Senior Regulatory Affairs Specialist will be responsible for supporting the AI-related projects across the Dexcom software products and platforms contributing to regulatory submissions globally and facilitating the adoption of AI processes and procedures. The Senior Regulatory Affairs Specialist will work with software/AI R&D quality assurance/compliance marketing and legal teams to ensure compliance with applicable premarket and post market activities throughout lifecycle of AI-related software products. .

Where you come in:

• You are the RA representative on core functional teams viewed as an expert in the field for global software regulatory classification change management and regulatory submissions including:
  • US 510(k) pre-submissions LTF/MTF change assessment
  • CE-marked products under EU MDR and EU AI Act: change notifications technical documentation update and submissions notified body/authorized representative communication
  • ROW: work with regulatory bodies or in-country representatives for device classification change assessment registration and amendments.
• You will work closely with SW R&D development engineering architecture quality compliance legal and cybersecurity teams to support the software development Total Product Lifecycle processes and documentation to meet regulatory quality system and compliance requirements.
• You are responsible for reviewing and reporting of global software and AI-related initiatives regulatory standards requirements and guidance from regulatory authorities to meet AI process and documentation requirements for global submissions.

What makes you successful:

• Your experience in software as a medical device (SaMD) regulation relevant FDA guidance documents MDCG guidance documents ISO and IEC standards (ISO-14971 IEC 62304) to effectively advise on regulatory strategy.
• Your experience or knowledge relating to Artificial Intelligence-enabled technologies including but not limited to: AI engineering Large Language Models neural networks.
• Your experience or knowledge relating to software including but not limited to: software development quality and design lifecycle methodology (e.g. Agile).
• You have excellent writing skills in regulatory documentation including classification memos change assessment/notifications technical dossier and submissions. You have experience interacting with regulators.
• You are passionate about digital health products in a regulated environment strong understanding of mobile/web app development AI/ML technologies analytics and working knowledge of agile software development methodologies.
• You have effective verbal and written communication skills.

What youll get:

• A front row seat to life changing CGM technology.Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative industry-leading organization committed to our employees customers and the communities we serve.

Travel Required:

• 5-15%

Experience and Education Requirements:

• Bachelors degree with a minimum of 5 years of relevant experience in medical device industry in functions such as software/AI engineering regulatory affairs software quality
• A minimum of 2 years of regulatory affairs experience required

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may at its discretion assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process please contact Dexcom Talent Acquisition at

Meritain an Aetna Company creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files please click on the URL provided: all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

Salary: