Regulatory Science & Policy Director

Job Title

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.

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 recommendations to ensure proactive adaptation to regulatory changes and minimizing compliance risks.
• Develops & 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.

You're the right fit if:

• 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 regulatory compliance topics, fostering a culture of continuous learning and adherence to standards and ensuring that all employees are well-informed about regulatory requirements and their roles in maintaining compliance.
• 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 accommodation for this

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  Company

  Philips

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