Head of Safety, Quality & Regulatory- Oral Health Care

The Head of Safety, Quality & Regulatory is accountable for oversight of 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.

Your role:

• 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, global regulatory strategies and roadmaps are in place and compliance data is timely generated, ensuring global regulatory and quality compliance.
• 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 evolving regulations to advise senior leadership on strategic decisions.
• Ensures that regulatory compliance activities are executed on time and 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.
• Leads teams in both Product Quality Engineering as well as Regulatory Compliance activities.
• Drives talent development initiatives to strengthen quality systems and organizational capabilities. Leads teams by providing guidance, managing talent, and driving succession planning.
• 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.
• The role addresses complex issues by analyzing situations with a deep understanding of the organization, contributing to the development and refinement of organizational objectives and principles.
• Interacts and builds strong relationships with development teams in Bothell (USA), Shenzhen (China) and other locations, as well as with the Strategic Business Development roles in Amsterdam (NL).

You're the right fit if:

• You have 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.
• You have proven experience in strategic and functional team leadership, including mentoring, budgeting, training, succession planning, hiring, performance management and technical or professional development of team members.
• You have proven expertise in all aspects related to Design Quality and Controls, with experience in Risk Management-FMEA/ISO 14971, Reliability, Biocompatibility (ISO10993-1) and Hazardous Substance Management.
• You have a minimum of a Bachelor’s Degree (Required) in Quality, Engineering or similar disciplines.
• You must be able to successfully perform the minimum physical, cognitive and environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than apart. For

Office-based

teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at customers’ or suppliers’ locations.

This is an Office role

.

About Philips:

We are a health technology company.