Sr Manager Regulatory Affairs

DexCom-posted 3 months ago
$141,800 - $236,400/Yr
Full-time • Senior
San Diego, CA
5,001-10,000 employees
Miscellaneous Manufacturing
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The Sr. manager, Regulatory Affairs will work within regulatory affairs and with cross functional teams to lead RA efforts for Dexcom's SaMD products and solutions. The Sr Manger will be responsible for 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 Manager will also lead regulatory strategy for novel digital health tools and features through interactions with regulatory agencies. The Sr Manager will work with software, algorithm development R&D, quality assurance teams to help streamline internal processes in compliance to applicable FDA guidance documents and international standards.

  • 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.
  • Supervise a team of regulatory affairs specialists.
  • Act as 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.
  • Manage CE-marked products under EU MDR: change notifications, technical file update, MDSS notifications and in-country registrations.
  • Collaborate with regional regulatory teams to support interactions with regulatory bodies or in-country representatives for device classification assessments, registration and amendments.
  • Work with SW development, cybersecurity, architect, quality, product management, and medical/clinical affairs to develop and implement streamlined software product development and design control processes to meet regulatory compliance requirements.
  • Represent RA in assessment of global cybersecurity, data availability and data privacy initiatives.
  • Advise on regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions.
  • 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.
  • 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).
  • Excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions.
  • Experience in interactions with regulators.
  • Passionate about digital health products in a regulated environment.
  • Strong understanding of mobile/web development, AI/ML technologies, analytics and working knowledge of agile software development methodologies.
  • Excellent verbal and written communication skills.
  • A front row seat to life changing CGM technology.
  • 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.
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