Director Regulatory Affairs (Medical Devices)

Job Title

Job Description

Job title:
Director Regulatory Affairs 

In this role, you have the opportunity to

We are seeking a dynamic and experienced Regulatory director to drive strategic regulatory initiatives, ensuring compliance and excellence across global business units. This individual will lead a team of 10+ professionals, focusing on Corrective and Preventive Actions (CAPAs), and sustaining business operations. The ideal candidate possesses deep expertise in regulatory affairs, strategic process optimization, and global regulatory policy development. This role significantly impacts organizational success, influencing regulatory outcomes, site leadership strategies, and business continuity.

You are responsible for

• Lead and mentor a team of 10+ regulatory professionals, fostering a culture of excellence and continuous improvement.

• Develop and implement long-term regulatory optimization and streamlining initiatives to enhance compliance and business efficiency.

• Provide strategic leadership in global regulatory matters across diverse product categories, including medical device classes, and software.

• Drive the development and influence of global regulatory policies to align with evolving industry standards.

• Oversee the authoring and submission of regulatory documentation, including FDA Pre-Submissions, 510(k)s, and Technical Files/Design Dossiers.

• Define and execute short to mid-term (1-3 years) regulatory strategy in alignment with organizational objectives.

• Serve as a key site leader, ensuring regulatory compliance and driving sustainable business practices.

• Plan, staff, budget, and manage priorities for the regulatory function while proposing and implementing methodological improvements.

• Lead succession planning and talent management initiatives, including employee selection, performance management, compensation management, and career development.

• Address complex regulatory and business challenges, collaborating across functions and regions to drive favorable outcomes.

• Influence senior management, executives, and key stakeholders, negotiating matters of strategic significance.

• Ensure financial and operational effectiveness within the regulatory function, impacting overall business performance and compliance success.

You are a part of

The global Philips regulatory organization and will be reporting to the Head of Regulatory Affairs for Image Guided Therapy Systems (IGT-S) in the Netherlands.  The team you will be working in, is a high-performance, culturally diverse, and very dynamic team.  

To succeed in this role, you should have the following skills and experience

• Bachelor’s or Master’s Degree in Biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law, or a related field.

• 10-12 years of experience in Regulatory Affairs, or Product Development within the Medical Device Industry (or equivalent).

• 6-8 years of management experience, leading regulatory teams in a global environment.

• Proven ability to develop and implement regulatory strategies, optimize compliance processes, and drive business continuity.

• Extensive knowledge of global regulatory requirements and experience authoring regulatory submissions.

• Strong leadership, communication, and negotiation skills, with the ability to influence senior executives and key stakeholders.

• Experience in managing complex regulatory challenges, collaborating across business units, and ensuring successful regulatory outcomes.

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.

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 the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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