Manager, Regulatory Compliance

Verathon-posted 1 day ago
$104,633 - $161,896/Yr
Full-time • Manager
Bothell, WA
501-1,000 employees
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The Manager, Regulatory Compliance will lead Verathon’s compliance team with focus on internal/external audits, European compliance, distributor and service partner compliance, sterilization oversight, management reviews, and QMS updates. This manager will report to the VP Quality & Regulatory and will lead a small team as well as complete individual contributor tasks. This manager will coordinate cross-functionally and sustain year-round inspection readiness.

  • Plan, lead, and continually improve the internal audit program; ensure effective risk-based coverage and timely closure of findings.
  • Lead and coordinate external inspections and audits by regulators, Notified Bodies, and MDSAP Auditing Organizations, including front-room/back-room operations and rapid response management.
  • Lead audit finding response management (containment, root cause, corrective action, effectiveness verification) and track commitments to on-time closure.
  • Maintain EU audit/inspection readiness and post-audit follow-through in collaboration with relevant EU stakeholders and company leadership.
  • Establish and maintain compliance qualification, due diligence, and ongoing monitoring programs for distributors and service partners.
  • Implement agreements, training, and periodic assessments; ensure complaint handling, traceability, field action support, and recordkeeping meet company requirements.
  • Own the sterilization validation process, routine control evidence, and change impact assessments with manufacturing and suppliers.
  • Audit and manage performance of sterilization service providers in collaboration with Supply Chain/Operations.
  • Lead management reviews including gathering inputs, metrics/KPIs, minutes, and action tracking to effectiveness.
  • Manage Regulatory Compliance Specialists and support staff; set objectives, coach performance, and build audit/inspection skills across the team.
  • Provide clear guidance to functional partners on readiness, roles, and communication during audits and inspections.
  • Bachelor’s degree in a scientific or engineering discipline (or equivalent experience).
  • A minimum of 3 years’ experience working in a regulated environment.
  • A minimum of 2 years’ people leadership.
  • Must be a critical thinker, detailed oriented with strong, structured, critical thinking skills, able to lead multiple team members and effectively balance priorities.
  • Must have proven experience working collaboratively in cross functional teams to continually improve a quality system.
  • Direct experience maintaining distributor and service partner compliance programs.
  • Practical knowledge of sterilization oversight (validation status, routine control evidence, supplier performance, change impact).
  • Strong technical writing for audit responses, management review materials, and executive updates.
  • Demonstrated skill in CAPA, risk-based prioritization, metrics, and effectiveness verification.
  • Lead Auditor or ASQ Certification is preferred.
  • Verathon provides a competitive benefits package including medical, dental, vision, basic life insurance, paid holidays, paid time off and a 401(k) matching plan.
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