Sr Regulatory Affairs Specialist
$91,400–$152,300 year
On-siteSan Diego, California, United States
San Diego, California, United StatesOn-siteFull Time$91,400–$152,300 yearSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Lead regulatory efforts for Dexcom's software products, including mobile applications, AI/ML enabled data products, and cloud-based solutions. Support product classifications, change assessments, registration, and approval across US 510(k), EU MDR, and ROW submissions. Collaborate with marketing, software, R&D, and quality assurance teams to streamline internal processes in compliance with FDA guidance, international standards, and cybersecurity initiatives. Represent the RA team in global cybersecurity and data privacy assessments and advise on regulatory strategy for submissions.
Required Qualifications
- Bachelor's degree
- 5 – 8 years of related experience
- Experience in SaMD regulations
- Experience with relevant FDA guidance documents
- Experience with MDCG guidance documents
- Experience with ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304)
- Excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions
- Experience interacting with regulators
- Passion for digital health products in a regulated environment
- Strong understanding of mobile/web development
- Strong understanding of AI/ML technologies
- Working knowledge of agile software development methodologies
- Effective verbal and written communication skills
- Must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km)
- Must be able to travel 5-15%
Desired Qualifications
- Strong understanding of cybersecurity initiatives
- Strong understanding of data privacy initiatives
- Strong understanding of regulatory standards, requirements and guidance from regulatory authorities
- Strong understanding of security process and documentation requirements for global submissions
- Strong understanding of global software regulatory classification
- Strong understanding of change management
- Strong understanding of regulatory submissions including: US 510(k), pre-submissions, LTF, MDDS change assessment
- Strong understanding of CE-marked products under EU MDR: change notifications, technical file update and submissions
- Strong understanding of MDSS notifications and in-country registrations
- Strong understanding of ROW: work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments
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