Head of Safety, Quality & Regulatory- Oral Health Care

About the role

The Head of Safety, Quality & Regulatory is accountable for overseeing product, hardware and software quality, risk management, and product regulatory activities throughout the product life cycle, ensuring market delivery of safe, effective, and compliant products in line with the Oral Healthcare business objectives.

Responsibilities

• Leads the full design lifecycle, from value proposition creation to end of life, including design input process, design V&V activities, design transfer, product realization, and performance in the field to ensure that all design requirements are met.
• Develops and executes robust product V&V and process validation strategies using and developing capabilities in advanced statistics to ensure smooth, compliant product launches.
• Oversees design evaluations and root cause analyses to proactively resolve quality issues and uphold quality and regulatory standards.
• Ensures that global regulatory strategies and roadmaps are created aligned with market trends, legislation, product marketing objectives, and staying current on evolving regulations to advise senior leadership on strategic decisions.
• Ensures that the regulatory compliance activities are executed on time and are maintained during the product lifecycle.
• Ensures that Post Market Surveillance and reliability data is integrated into lifecycle processes to improve product quality and compliance.
• Directs audit readiness and strategic responses to inspections, ensuring full alignment with internal and external quality and regulatory expectations.
• Promotes advanced Quality Engineering practices across teams to drive continuous improvement and excellence.
• Drives talent development initiatives to strengthen quality systems and organizational capabilities.
• Leads teams in both Product Quality Engineering as well as Regulatory Compliance activities.
• Provides strategic direction to managers in different departments, identifying opportunities for quality improvement and innovation, and promoting a culture of quality excellence and continuous improvement.

Requirements

Your Role requires a minimum of 15+ years’ experience in Product Design Quality/Control/Regulatory Affairs in combination with extensive experience in both ISO 13485 Medical Device/Technology and ISO 9001, with extensive design/development experience in (FDA) Class I medical device, consumer goods, and cosmetics. Proven expertise in all aspects related to Design Quality/Controls, including Risk Management-FMEA/ISO 14971, Reliability, Biocompatibility (ISO10993-1), and Hazardous Substance Management. A minimum of a Bachelor’s Degree (Required) in Quality, Engineering, or similar disciplines. Must be able to successfully perform the following minimum Physical, Cognitive, and Environmental job requirements with or without accommodation for this position.

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Bothell, WA is $181,000 to $288,960.

Schedule

This is an Office role.

Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Additional Information

For this position, you must reside within commuting distance to Bothell, WA or be willing/able to relocate to the Bothell, WA area with assistance. May require travel up to 10%.