Verathon · 8 hours ago
Regulatory Compliance Manager
Bothell, WA
Full-time
Onsite
Mid, Senior Level
$105K/yr - $162K/yr
3+ years expVerathon is a company focused on regulatory compliance within the medical device industry. The Manager, Regulatory Compliance will lead the compliance team, focusing on audits, compliance oversight, and maintaining inspection readiness.
Manufacturing
Hiring Manager
Lindsey Nakashima
Responsibilities
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
Qualification
Required
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
Proven experience leading confidently under pressure during external audits
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
Preferred
Lead Auditor or ASQ Certification
Benefits
Medical
Dental
Vision
Basic life insurance
Paid holidays
Paid time off
401(k) matching plan
Company
Verathon
Verathon has designed, manufactured and marketed pioneering medical devices.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2009-11-09Acquired
Leadership Team
Tracy Olson
Vice President, Finance & Chief Financial Officer
Recent News
Research and Markets
2025-04-26
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