Philips Regulatory Affairs Program Manager 

United States, Washington, Bothell 

910057487

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 .

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.

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Philips Transparency Details:

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

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%.