Job Title

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).

Your role:

• 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

You're the right fit if:

• You’ve acquired a minimum of 7 years’ experience in Regulatory Affairs within FDA regulated medical device/software (SaMD, SiMD) environments, AED’s/Defibrillators or other Class III Devices containing medical electrical equipment highly desired.
• You have expertise in software specific regulatory guidance/requirements, standards including IEC 62304), SaMD (IEC 82304), TIR45, Artificial Intelligence (AI), cybersecurity, and human factors (IEC 62366). algorithms and experience with AED’s/Defibrillators or other Class III Devices highly desired.
• You’ve acquired extensive experience and knowledge of global medical device regulations, guidance, and applicable standards including original PMA, PMA supplements, pre-submission 510K, De Novo, Technical Documentation preparation and associated guidance, standards.
• You have a proven track record of working/communicating effectively with Global cross-functional teams and with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities).
• You have In-depth knowledge of FDA regulations (ISO/IEC/CFR) related to risk management and the development of safe software products including ISO 14971, ISO 13485, 21CFR 820, EU MDR, IEC 82304, IEC 62304, and IEC 62366-1
• You have a Minimum of a Bachelor’s Degree (Required) in Regulatory Affairs, Biomedical Engineering, Clinical/Life Science or similar disciplines. Master’s Degree desired. RAC Certification 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 outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

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 improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our commitment to diversity and inclusion.

Philips Transparency Details:

• The pay range for this position in Bothell, WA is $128,000 to $205,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA.
• May require travel up to 10%.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.