Sr Regulatory Affairs Specialist

DexCom • San Diego, CA

2d • Remote

About The Position

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 Sr. Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to lead RA efforts for advertising and promotion as well as Dexcom’s software products. The Sr. Regulatory Affairs Specialist will be responsible for advertising/promotion material review, supporting product classifications, change assessments, registration and approval for software products, including mobile applications, AI/ML enabled data products, cloud-based solutions and cybersecurity initiatives. The Sr. Regulatory Affairs Specialist will work with marketing, software, algorithm development R&D, and quality assurance teams to help streamline internal processes in compliance to applicable FDA guidance documents and international standards. Where you come in: You are the RA representative on core functional teams for advertising and promotion and global software regulatory classification, change management, and regulatory submissions including: US 510(k), pre-submissions, LTF, MDDS change assessment CE-marked products under EU MDR: change notifications, technical file update and submissions, MDSS notifications and in-country registrations ROW: work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments You will work closely with SW development, engineering, architect, quality and cybersecurity teams to develop and implement streamlined software development processes and documentation to meet regulatory, quality system and compliance requirements You are responsible for advising on and representing RA in the assessment of global cybersecurity and data privacy initiatives, regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions.

Requirements

• Experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to effectively advise on regulatory strategy
• Excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions.
• Experience interacting with regulators.
• Passionate about digital health products in a regulated environment, strong understanding or mobile/web development, AI/ML technologies, analytics and working knowledge of agile software development methodologies.
• Effective verbal and written communication skills
• Bachelor’s degree with a minimum of 5 years of relevant experience in medical device industry in functions such as software engineering, regulatory affairs, software quality, digital health product management
• A minimum of 2 years of regulatory affairs experience required

Responsibilities

• RA representative on core functional teams for advertising and promotion and global software regulatory classification, change management, and regulatory submissions including: US 510(k), pre-submissions, LTF, MDDS change assessment CE-marked products under EU MDR: change notifications, technical file update and submissions, MDSS notifications and in-country registrations ROW: work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments
• Work closely with SW development, engineering, architect, quality and cybersecurity teams to develop and implement streamlined software development processes and documentation to meet regulatory, quality system and compliance requirements
• Advising on and representing RA in the assessment of global cybersecurity and data privacy initiatives, regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees