Dexcom · 1 day ago

Sr Regulatory Affairs Specialist

United States

Full-time

Remote

Mid, Senior Level

$87K/yr - $145K/yr

5+ years exp

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Responsibilities

You are the 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

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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

SaMD regulationsFDA guidance documentsISO standardsIEC standardsRegulatory submissionsDigital health productsMobile/web developmentAI/ML technologiesMedical device industryRegulatory affairsTechnical writingAgile methodologiesSoftware qualityDigital health product management

Required

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

Your 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

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 or mobile/web development, AI/ML technologies, analytics and working knowledge of agile software development methodologies.

You have effective verbal and written communication skills