Regulatory Transformation Leader

Job Title

Regulatory Transformation Leader

Job Description

In late January, Philips announced that Bridgefield Capital signed an agreement to acquire Philips’ Emergency Care business which includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions. We expect the transaction to close at the end of 2025. With Bridgefield’s support and building on our 40+ year legacy of growth and innovation in emergency medical technology, the Emergency Care business will continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments.

In this Regulatory Transformation Leader role and as part of an agile company that has the dedicated resources needed to achieve its strategic goals, you’ll have every opportunity to grow both personally and professionally and potentially make an even bigger impact on the acute care space – as well as on the consumers, patients and healthcare workers who depend on these innovative life-saving solutions.

The Regulatory Transformation Leader is responsible for aligning Philips/ Bridgefield Capital’s regulatory transformation strategies with business unit objectives, ensuring seamless integration of regulatory requirements, regulatory excellence, and continuous improvement into the Emergency Care business unit.

Your role:

• Aligns regulatory strategies with business objectives to ensure seamless integration of regulatory requirements into product development and commercialization, with a focus on planning and executing business transformation and productivity improvements.
• Communicates effectively with cross‐functional teams and regulatory agencies (e.g. Notified Bodies, FDA, Competent Authorities), ensuring clarity, transparency, and a proactive approach in all regulatory affairs activities to maintain an end‐to‐end perspective on enhancing efficiency and effectiveness throughout the value chain.
• Drives continuous improvement initiatives, builds strategic partnership with stakeholders, and implements automation and technologies to enhance efficiency.
• Develops and drives implementation of robust regulatory policies and procedures, ensuring consistent adherence to compliance standards across all business units, and regularly updates them to reflect the latest regulatory changes.
• Responsible for identifying/enhancing cost‐saving, state of the art, and compliance improving opportunities through the optimization and streamlining of processes and tools, as well as opportunities to implement efficient processes and recommends suitable changes to Philips' regulatory processes.
• Evaluates new regulatory guidelines and standards, conducting thorough impact assessments on current and future products, and advising on necessary strategic adjustments to maintain compliance.
• Sponsors strategic projects, facilitates stakeholder management/reviews and approves the creation or modification of operational infrastructures to support strategic objectives and drive sustainable results.

You're the right fit if:

• You’ve acquired a minimum of 7 years’ experience in Regulatory Affairs within FDA regulated medical device environments, with a focus on Regulatory Strategy/ Requirements, International/US Medical Device Regulations, registrations and listings, Project Management, Continuous Improvement and Regulatory Transformation initiatives.
• You have detailed experience with Class II/II Medical Devices, experience with Automated External Defibrillators (AED’s)/Defibrillators is highly desired.
• You’re experienced in working with/communicating effectively with Global cross-functional teams and managing Internal/external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities).
• You have a Minimum of a Bachelor’s Degree (Required) in Regulatory Affairs, Biomedical Engineering, Clinical/Life Science or similar disciplines. RAC and/or Six Sigma Certifications desired.
• You must be able to successfully perform the following minimum 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 a part. 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 outs