Sr Regulatory Affairs Specialist

Dexcom; United States; Remote; USD 91,000 - 153,000; Full time

Job summary

Dexcom is seeking a Senior Regulatory Affairs Specialist to support AI-related projects within its medical device software. This role involves regulatory submissions, working with cross-functional teams to ensure compliance with software development regulations and standards, and contributing to the advancement of digital health technologies.

Benefits

Full and comprehensive benefits program

Growth opportunities on a global scale

Access to career development programs

Innovative, industry-leading organization

Qualifications

• 5 years of relevant experience in medical device industry.
• 2 years of regulatory affairs experience.
• Experience with FDA guidance and ISO standards.

Responsibilities

• Act as RA representative on core functional teams for regulatory submissions.
• Support software development lifecycle for compliance.
• Review regulatory standards for AI-related software products.

Skills

Regulatory strategy

AI engineering

Software development

Writing regulatory documentation

Digital health products knowledge

Education

Bachelor’s degree

Job description

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 we're 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 we've 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. We've already changed millions of lives and we're 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. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've 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 we're 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 we've 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. We've already changed millions of lives and we're 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. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've 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 Dexcom’s 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 you’ll 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:

• Bachelor’s 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. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

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 [e-mail].

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: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

To 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:

$91,400.00 - $152,300.00