Regulatory Science & Policy Director

Koninklijke Philips N.V

5d • Onsite

About The Position

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.
Your role:
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 rmendations to ensure proactive adaptation to regulatory changes and minimizingpliance risks.
Develops & facilitatesprehensive productpliance strategies that align with risk andpliance domains, ensuring these strategies are integrated into business processes and consistently add to across theanization.
Participates in regulatory discussions actively to shape favorable regulatory environments and maintain strong relationships with regulatory authorities, coordinating with regulatory bodies, industryanizations, 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,municating 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 inpliance activities, leveraging industry best practices and technological advancements to streamline regulatory processes.
Utilizes advanced knowledge of global applicable regulations to resolveplex regulatory challenges, working closely with product teams to ensure Philips' products meet all necessary standards for market approval, providing expert guidance on regulatory strategy andpliance 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 openmunication and collaboration to ensure regulatorypliance efforts are well-coordinated and supported.
Ensures implementation of policies and procedures to drive continuous improvement initiatives that enhancepliance, efficiency, andanizational effectiveness, ensuring alignment with risk andpliance domains and industry best practices.

Requirements

• You've acquired a minimum of 10+ years' experience 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.
• You have a demonstrable history of success in a regulatory or health policy role, strong understanding of regulatory and legislative environments, with strong experience building/fostering strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Health Authorities).
• You have proven experience in preparing/delivering training sessions and informational materials to internal teams on regulatorypliance topics, fostering a culture of continuous learning and adnce to standards and ensuring that all employees are well-informed about regulatory requirements and their roles in maintainingpliance.
• You have 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.
• You have a minimum of a Bachelor's degree (required); Master's or Advanced degree-JD, Regulatory Science (preferred).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this position.

Nice To Haves

• Master's or Advanced degree-JD, Regulatory Science (preferred).

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 rmendations to ensure proactive adaptation to regulatory changes and minimizingpliance risks.
• Develops & facilitatesprehensive productpliance strategies that align with risk andpliance domains, ensuring these strategies are integrated into business processes and consistently add to across theanization.
• Participates in regulatory discussions actively to shape favorable regulatory environments and maintain strong relationships with regulatory authorities, coordinating with regulatory bodies, industryanizations, 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,municating 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 inpliance activities, leveraging industry best practices and technological advancements to streamline regulatory processes.
• Utilizes advanced knowledge of global applicable regulations to resolveplex regulatory challenges, working closely with product teams to ensure Philips' products meet all necessary standards for market approval, providing expert guidance on regulatory strategy andpliance 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 openmunication and collaboration to ensure regulatorypliance efforts are well-coordinated and supported.
• Ensures implementation of policies and procedures to drive continuous improvement initiatives that enhancepliance, efficiency, andanizational effectiveness, ensuring alignment with risk andpliance domains and industry best practices.

Benefits

• Employees are eligible to participate in ourprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (withpany contribution), stock purchase plan, education reimbursement and .
• Details about our benefits can be found .

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees