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Dexcom Deutschland GmbH · 1 week ago

Sr Manager Regulatory Affairs

San Diego, CA

Full-time

Hybrid

Senior Level, Lead/Staff

$142K/yr - $236K/yr

13+ years exp

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Sr Manager of Regulatory Affairs will lead regulatory efforts for SaMD products, manage a team, and ensure compliance with regulatory standards while working closely with cross-functional teams.

Medical Device

Responsibilities

You will spearhead regulatory strategy and execution for SaMD and SiMD products, features, cloud-based solutions, data connectivity and integration efforts, and other software components within the Dexcom digital health ecosystem. You will also supervise a team of regulatory affairs specialists

You are the RA lead on core functional teams for global software regulatory classification, change management, regulatory submissions including:

US 510(k), pre-submissions, LTF, MDDS change assessment

CE-marked products under EU MDR: change notifications, technical file update, MDSS notifications and in-country registrations

ROW: work with regional regulatory teams to help support interactions with regulatory bodies or in-country representatives for device classification assessments, registration and amendments

You will work with SW development, cybersecurity, architect, quality, product management. Medical/clinical affairs and other cross functional teams to develop and implement streamlined software product development and design control processes to meet regulatory compliance requirements

You will represent RA in assessment of global cybersecurity, data availability and data privacy initiatives. You are responsible for advising on regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions

Qualification

Regulatory AffairsSaMD RegulationsFDA GuidanceDigital Health ProductsAI/ML TechnologiesSoftware DevelopmentTeam ManagementCommunication SkillsTechnical Writing

Required

Typically requires a Bachelor's degree with 13+ years of relevant experience in medical device industry in functions such as engineering, regulatory affairs, software quality, digital health product and program management

5-8 years of previous people management experience

A minimum of 5 years of regulatory affairs experience

You have a strong track record interpreting and implementing SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to advise on regulatory strategy

You have excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions. You are experienced in interactions 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 excellent verbal and written communication skills, and success in managing a team