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.
• Oversee 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.
• Leads teams in both Product Quality Engineering as well as Regulatory Compliance activities
• Drive 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 build strong relationships with development teams in Bothell (USA), Shenzhen (China) and other locations, as well 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/functional team leadership, including
  mentoring, budgeting, training, succession planning, hiring, performance
  management and technical/professional development of team members.
• You have proven expertise in all aspects related to Design Quality/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 following 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 a part. For our 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 the customers’ or suppliers’ locations. This is an Office role.

About 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.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

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

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA.
• May require travel up to 10%.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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 strategiesusing and developing capabilities in advanced statistics to ensure smooth,compliant product launches. Oversee design evaluations and root cause analyses to proactively resolvequality issues and uphold quality and regulatory standards. Ensures that global regulatory strategies and roadmaps are created aligned withmarket trends, legislation, product marketing objectives and staying current onevolving regulations to advise senior leadership on strategic decisions. Ensures that the regulatory compliance activities are executed on time and aremaintained 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 fullalignment with internal and external quality and regulatory expectations. Promotes advanced Quality Engineering practices across teams to drivecontinuous improvement and excellence. Leads teams in both Product Quality Engineering as well as Regulatory Compliance activities. Drive 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, identifyingopportunities 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 build strong relationships with development teams in Bothell (USA), Shenzhen (China) and other locations, as well 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 inboth ISO 13485 Medical Device/ Technology and ISO 9001, with extensivedesign/development experience in (FDA) Class I medical device, consumergoods and cosmetics. You have proven experience in strategic/functional team leadership, includingmentoring, budgeting, training, succession planning, hiring, performancemanagement and technical/professional development of team members. You have proven expertise in all aspects related to Design Quality/ Controls, withexperience in Risk Management-FMEA/ ISO 14971, Reliability, Biocompatibility(ISO 10993-1) 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 following 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 a part. For our 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 the customers’ or suppliers’ locations. This is an Office role.

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