Regulatory Science & Policy Director

Philips • DC

106d • $172,200 - $275,520

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 includes guiding 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. You will develop and facilitate 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. Additionally, you will participate 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. You will monitor 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. You may be responsible for conducting reviews and providing feedback on regulatory aspects of product development and marketing plans, ensuring alignment with global regulatory requirements, and offering strategic input during product design and development phases to preemptively address potential regulatory challenges. Furthermore, you will optimize 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. You will utilize 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. Building and maintaining effective relationships with internal and external stakeholders, including regulatory bodies, industry groups, and cross-functional teams within Philips, will be crucial to facilitate open communication and collaboration to ensure regulatory compliance efforts are well-coordinated and supported. Finally, you will ensure 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.

Requirements

• Minimum of 10+ years’ experience in FDA Regulations, Global Regulatory Affairs, Policies and Standards within the Medical Device/Technology industry or Health Authority (FDA).
• Proven experience in Strategic Regulatory program leadership.
• Demonstrable history of success in a regulatory or health policy role.
• Strong understanding of regulatory and legislative environments.
• Experience building/fostering strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Health Authorities).
• Proven experience in preparing/delivering training sessions and informational materials on regulatory compliance topics.
• Extensive experience in planning in-depth research on regulatory issues and trends.
• Minimum of a Bachelor’s degree (required); Master’s or Advanced degree-JD, Regulatory Science (preferred).

Responsibilities

• Guide the analysis of global regulatory requirements and industry standards to identify their potential impacts on Philips products and services.
• Develop and facilitate comprehensive product compliance strategies that align with risk and compliance domains.
• Participate in regulatory discussions to shape favorable regulatory environments and maintain relationships with regulatory authorities.
• Monitor changes in global applicable regulations and standards, communicating relevant updates to internal stakeholders.
• Conduct reviews and provide feedback on regulatory aspects of product development and marketing plans.
• Optimize regulatory processes and workflows by identifying inefficiencies and implementing improvements.
• Utilize advanced knowledge of global applicable regulations to resolve complex regulatory challenges.
• Build and maintain effective relationships with internal and external stakeholders.
• Ensure implementation of policies and procedures to drive continuous improvement initiatives.

Benefits

• Generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees