Head of Safety, Quality & Regulatory- Oral Health Care
Location
Bothell, WA
Level
VP / Executive
Department
MedTech
Type
Salary
$181,000 - $289,000
Job Description
Posted on:
2026-04-21
Responsibilities
- Lead the full design lifecycle from value proposition to end of life.
- Develop and execute product V&V and process validation strategies.
- Oversee design evaluations and root cause analyses to resolve quality issues.
- Ensure regulatory strategies align with market trends and compliance data is generated timely.
- Direct audit readiness and strategic responses to inspections.
- Promote advanced Quality Engineering practices across teams.
- Provide strategic direction and mentorship to team members.
Job Requirements
- Minimum of 15+ years’ experience in Product Design Quality/Control/Regulatory Affairs.
- Extensive experience with ISO 13485 and ISO 9001, and FDA Class I medical devices.
- Proven leadership experience in mentoring, budgeting, and performance management.
- Expertise in Design Quality/Controls, Risk Management-FMEA, and Hazardous Substance Management.
- Bachelor’s Degree in Quality, Engineering, or similar disciplines required.
- Ability to meet physical, cognitive, and environmental job requirements.
- Must reside in or near Bothell, WA, with the ability to travel up to 10%.
