Philips
Regulatory Science & Policy Director – Job Description
The Regulatory Science & Policy Director is responsible for guiding the analysis of global regulatory requirements, policies and industry standards to identify their potential impacts on Philips products and services.
Responsibilities
Guides the analysis of global regulatory requirements and industry standards to identify their potential impacts on Philips products and services, conducting thorough evaluations and providing strategic recommendations to ensure proactive adaptation to regulatory changes and minimizing compliance risks.
Develops and facilitates comprehensive product compliance strategies that align with risk and compliance domains, ensuring these strategies are integrated into business processes and consistently adhered to across the organization.
Participates in regulatory discussions actively to shape favorable regulatory environments and maintain strong relationships with regulatory authorities, coordinating with regulatory bodies, industry organizations, and key stakeholders to influence policy development and advocate for Philips' interests.
Monitors changes in global applicable regulations and standards by actively engaging with regulatory bodies and industry groups, communicating relevant updates to internal stakeholders through detailed reports and presentations, may be responsible to conduct reviews and provide feedback on regulatory aspects of product development and marketing plans, ensuring alignment with global regulatory requirements, offering strategic input during product design and development phases to preemptively address potential regulatory challenges.
Optimizes regulatory processes and workflows by identifying inefficiencies and implementing improvements to enhance operational efficiency and effectiveness in compliance activities, leveraging industry best practices and technological advancements to streamline regulatory processes.
Utilizes advanced knowledge of global applicable regulations to resolve complex regulatory challenges, working closely with product teams to ensure Philips’ products meet all necessary standards for market approval, providing expert guidance on regulatory strategy and compliance to support successful product launches and market expansions.
Builds and maintains effective relationships with internal and external stakeholders, including regulatory bodies, industry groups, and cross‑functional teams within Philips, facilitating open communication and collaboration to ensure regulatory compliance efforts are well‑coordinated and supported.
Ensures implementation of policies and procedures to drive continuous improvement initiatives that enhance compliance, efficiency, and organizational effectiveness, ensuring alignment with risk and compliance domains and industry best practices.
Qualifications
Minimum of 10+ years in FDA Regulations, Global Regulatory Affairs, Policies and Standards within the Medical Device/Technology industry or Health Authority (FDA), with proven experience in Strategic Regulatory program leadership.
Demonstrated success in a regulatory or health policy role, strong understanding of regulatory and legislative environments, with experience building and fostering strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Health Authorities).
Proven experience in preparing and delivering training sessions and informational materials to internal teams on regulatory compliance topics, fostering a culture of continuous learning and adherence to standards.
Extensive experience in planning in‑depth research on regulatory issues and trends, synthesizing findings into actionable insights, mentoring junior regulatory associates, and optimizing regulatory processes and workflows.
Minimum of a Bachelor’s degree (required); Master’s or Advanced degree‑JD, Regulatory Science (preferred).
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 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.
Pay Range Washington, DC – $172,200 to $275,520 (base pay).
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 Washington, DC.
May travel up to 10%.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.
#J-18808-Ljbffr
Responsibilities
Guides the analysis of global regulatory requirements and industry standards to identify their potential impacts on Philips products and services, conducting thorough evaluations and providing strategic recommendations to ensure proactive adaptation to regulatory changes and minimizing compliance risks.
Develops and facilitates comprehensive product compliance strategies that align with risk and compliance domains, ensuring these strategies are integrated into business processes and consistently adhered to across the organization.
Participates in regulatory discussions actively to shape favorable regulatory environments and maintain strong relationships with regulatory authorities, coordinating with regulatory bodies, industry organizations, and key stakeholders to influence policy development and advocate for Philips' interests.
Monitors changes in global applicable regulations and standards by actively engaging with regulatory bodies and industry groups, communicating relevant updates to internal stakeholders through detailed reports and presentations, may be responsible to conduct reviews and provide feedback on regulatory aspects of product development and marketing plans, ensuring alignment with global regulatory requirements, offering strategic input during product design and development phases to preemptively address potential regulatory challenges.
Optimizes regulatory processes and workflows by identifying inefficiencies and implementing improvements to enhance operational efficiency and effectiveness in compliance activities, leveraging industry best practices and technological advancements to streamline regulatory processes.
Utilizes advanced knowledge of global applicable regulations to resolve complex regulatory challenges, working closely with product teams to ensure Philips’ products meet all necessary standards for market approval, providing expert guidance on regulatory strategy and compliance to support successful product launches and market expansions.
Builds and maintains effective relationships with internal and external stakeholders, including regulatory bodies, industry groups, and cross‑functional teams within Philips, facilitating open communication and collaboration to ensure regulatory compliance efforts are well‑coordinated and supported.
Ensures implementation of policies and procedures to drive continuous improvement initiatives that enhance compliance, efficiency, and organizational effectiveness, ensuring alignment with risk and compliance domains and industry best practices.
Qualifications
Minimum of 10+ years in FDA Regulations, Global Regulatory Affairs, Policies and Standards within the Medical Device/Technology industry or Health Authority (FDA), with proven experience in Strategic Regulatory program leadership.
Demonstrated success in a regulatory or health policy role, strong understanding of regulatory and legislative environments, with experience building and fostering strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Health Authorities).
Proven experience in preparing and delivering training sessions and informational materials to internal teams on regulatory compliance topics, fostering a culture of continuous learning and adherence to standards.
Extensive experience in planning in‑depth research on regulatory issues and trends, synthesizing findings into actionable insights, mentoring junior regulatory associates, and optimizing regulatory processes and workflows.
Minimum of a Bachelor’s degree (required); Master’s or Advanced degree‑JD, Regulatory Science (preferred).
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 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.
Pay Range Washington, DC – $172,200 to $275,520 (base pay).
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 Washington, DC.
May travel up to 10%.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.
#J-18808-Ljbffr