Sr Regulatory Affairs Specialist

DexCom • San Diego, CA

1d • Remote

About The Position

The Sr. Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to lead RA efforts for Dexcom’s software products. The Sr. Regulatory Affairs Specialist will be responsible for 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.

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
• Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience.

Responsibilities

• RA representative on core functional teams for 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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior