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Head of Safety, Quality & Regulatory – Oral Health Care
PhilipsHead of Safety, Quality & Regulatory in health technology, leading product quality and regulatory compliance. Driving strategic decisions and continuous improvement across teams and locations.
About the role
Key responsibilities & impact- Accountable for oversight of product, hardware and software quality
- Leads the full design lifecycle from value proposition to end of life
- Develops and executes robust product V&V and process validation strategies
- Oversees design evaluations and root cause analyses
- Ensures regulatory compliance activities are executed on time
- Directs audit readiness and strategic responses to inspections
- Promotes advanced Quality Engineering practices across teams
- Leads teams in Product Quality Engineering and Regulatory Compliance activities
- Provides strategic direction to managers identifying quality improvement opportunities
Requirements
What you’ll need- 15+ years of experience in Product Design Quality/Control/Regulatory Affairs
- Extensive experience with ISO 13485 and ISO 9001
- Design/development experience in (FDA) Class I medical devices, consumer goods and cosmetics
- Proven experience in strategic/functional team leadership
- Expertise in Design Quality/Controls including Risk Management-FMEA/ISO 14971, Reliability, Biocompatibility (ISO10993-1)
- Minimum of a Bachelor's Degree in Quality, Engineering or similar disciplines
Benefits
Comp & perks- Health technology company
- Commitment to diversity and inclusion
- Equal employment opportunity
- Opportunities for professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Product Design QualityRegulatory AffairsRisk ManagementFMEAISO 13485ISO 9001ISO 14971BiocompatibilityReliabilityProcess Validation
Soft Skills
Team LeadershipStrategic DirectionQuality ImprovementCommunicationOversightAnalytical ThinkingProblem SolvingCollaborationOrganizational SkillsAudit Readiness