JOB DESCRIPTION

In late January we 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 Affairs Program Manager 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 Affairs Program Manager will play a critical role in preparing comprehensive regulatory strategies, submissions and post market changes for Class III Defibrillators, Automated External Defibrillator’s (AED’s) and associated Software/ Software as a medical Device (SaMD).

• Responsible for executing regulatory strategies, detailed regulatory plans and submissions for Class III Defibrillators, Automated External Defibrillator (AED), Software/ Software as a medical Device (SaMD).
• Educate and advise cross-functional teams on evolving regulatory requirements and best practices specific to SaMD, clinical evidence generation, and AI/ML-based medical devices. Provide clear and timely interpretation of global regulations that are actionable for assigned projects.
• Execute pre-market and post-market regulatory activities as per applicable procedures supporting software-enabled medical devices and Software as a medical Device (SaMD). with focus on major markets including the US, Canada and EU.
• Represent regulatory affairs in key activities including Quality Management Reviews, risk management, design reviews, portfolio selection process, change management, adoptions of new guidance / standards, post-market activities, audits, inspections.
• Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including, including design control activities, indications of risk and approximate timing for approval for planning purposes. Supports both new product development and currently marketed product portfolio