VP, Quality Compliance

DexcomSan Diego, CA
Remote

About The Position

The VP of Global Quality Compliance is accountable for ensuring global regulatory and compliance excellence across the organization. This role provides strategic and operational leadership for quality compliance activities, including audit readiness, health authority engagement, field actions, management review, and regulatory communications, ensuring sustained compliance with global regulatory requirements. This role is also a key member of the Global Quality Leadership Team.

Requirements

  • Extensive experience leading global Quality Compliance functions in a regulated environment.
  • Deep knowledge of FDA, EU MDR, ISO, and other global regulatory frameworks.
  • Proven ability to lead and influence at the executive and health authority levels.
  • Strong judgment, decisiveness, and ability to manage complex, high-risk compliance matters.
  • Organized, motivated and lead diverse teams in a quickly growing and agile/flexible corporate environment.
  • Demonstrated success building and leading high-performing global teams.
  • High level of collaboration and desire to reach across the organization to understand stakeholder needs and how to meet those needs.
  • Ability to operate strategically while driving strong operational execution.
  • Excellent written and verbal communication skills with executive presence.
  • Bachelor’s degree in a technical discipline

Responsibilities

  • Provide executive leadership for Global Quality Compliance across all regions and sites.
  • Own and oversee internal and external audit management activities, including inspections and certifications.
  • Lead Notified Body management, engagement, and reporting activities.
  • Serve as official company correspondent for FDA Establishment Registrations and EU MDR Person Responsible for Regulatory Compliance (PRRC) - Field Actions.
  • Lead FDA inspection responses and coordinate global regulatory authority communications.
  • Provide oversight of Health Hazard Evaluations (HHEs), Field Actions, recalls, and customer/regulatory communications.
  • Assess compliance of products and procedures with global regulatory requirements and drive the recall decision-making quorum.
  • Coordinate and oversee the corporate Quality Management Review and the monthly Management Business Review (MBR) processes.
  • Act as senior external liaison for regulatory and compliance authorities globally.
  • Direct and/or oversee investigations into quality or compliance concerns and escalate risks to executive leadership.
  • Ensure consistent compliance governance, policies, and procedures across global operations.
  • Review, approve and enforce site and corporate procedures as appropriate.
  • Coordinate and plan implementation or updating to IT systems to support compliance activities.

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.
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