Dexcom Employment – Manager Regulatory Affairs

Website Dexcom

Job Description:

Collaborate with Regulatory Affairs and cross-functional teams to obtain market clearances/approvals for new products, support existing products, develop regulatory strategy for submission of new products to US and/or OUS regulatory bodies.

Job Responsibilities:

  • Represent Regulatory Affairs on various cross-functional teams such as Corrective actions, corrections and removals, Design control, Document Control
  • Direct or conduct personnel training on FDA and ISO requirements.
  • Review and approve product labeling and marketing materials to ensure compliance with regulatory requirements.
  • Review and approve site and corporate procedures as appropriate.
  • Manage, coordinate and participate in the development of regulatory strategies and prepare regulatory submissions for current and future medical device products
  • Support Dexcom’s international offices on regulatory/compliance issues, as needed.
  • Participate in meetings with regulatory agencies (e.g., pre-sub meetings)
  • Canada submissions include Class III Medical Device Licence Applications and amendments
  • EU submissions include filing and amending Technical Documentation
  • US submissions include IDEs, 510(k)s and PMAs
  • Serve as a key opinion leader of Regulatory Affairs
  • Maintain knowledge on changing worldwide regulations and standards that are germane to Dexcom’s business.

Job Requirements:

  • Must work well independently or within a cross-functional team environment.
  • Technical background such as engineering, biological sciences, computer science to support collaboration with technical teams
  • Excellent verbal and written communication skills, with the ability to convey regulatory, quality, and business information clearly and effectively
  • through informal and formal documents, reports, and presentations.
  • Bachelor’s degree with 8 years of industry experience; higher degrees can substitute for years of experience.
  • Relevant work experience in medical device, with knowledge of diabetes
  • Experience in managing cross-functional projects.
  • Knowledgeable in evaluating clinical evaluation reports and clinical study protocols
  • Deep knowledge of US and OUS pre-market and post-market medical device regulatory/quality requirements.

Job Details:

Company: Dexcom

Vacancy Type: Full Time

Job Location: San Diego, CA, US

Application Deadline: N/A

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