Job Title

　　Head (Director) Regulatory Affairs-Clinical Applications & Devices

　　Job Description

　　The Head (Director) Regulatory Affairs- Clinical Applications & Devices (CAD) within the Hospital Patient Monitoring business will drive the development and deployment of innovative, compliant regulatory strategies, build regulatory capabilities, drive efficiencies through regulatory operations excellence and collaborate across Hospital Patient Monitoring (HPM) to build a regulatory vision that will inspire, while ensuring regulatory compliance and enabling HPM solutions.

　　 Your role: Will lead the strategic development and deployment of innovative Regulatory strategies with the HPM-CAD Regulatory Affairs team and cross-functional CAD teams, to bring products efficiently and compliantly to the market and maintain them compliantly to support business growth.Responsible for functional leadership of the CAD Regulatory Affairs Team: hiring, development of critical talent through creating and sustaining robust career & development plans, ongoing mentorship/coaching, feedback, and identifying and addressing gaps in capabilities and competencies.Leading performance management of the CAD Regulatory Affairs team, using metrics and key performance indicators to drive decision making, meaningful actions, and continuous improvement.Reporting to the Head of Regulatory Affairs-Hospital Patient Monitoring (HPM) you will collaborate with R&D, Quality, Clinical, PMO office, Supplier Quality/Procurement, and other partners to ensure regulatory inputs are fully deployed throughout product lifecycle management.This Hybrid role may require travel up to 10%. You're the right fit if:

　　You've acquired a minimum of 10 years' experience in Regulatory Affairs within FDA regulated medical device/technology environments, with a minimum of 3 years as a functional leader and a strong track-record of successfully bringing products to market on time.Your skills include experience in digital health, hospital patient management and software as a medical service (SaMD/SaaS), with strong, broad knowledge of regional and global medical device regulations, requirements, and standards.Your skills include detailed knowledge and expertise in authoring FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), PMA, Technical Files/Design Dossier, etc).You are experienced in building strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities); and have leadership presence to influence, inspire, and encourage successful collaboration in a highly matrixed environment.You have a minimum of a Bachelor's degree (Required), preferably in an Engineering, Life-Sciences or Regulatory discipline. Master's Degree desired.You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position . 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. 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. Read more about our employee benefits .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 .

　　 Philips Transparency Details:

　　The pay range for this position is $128,000 to $236,000, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

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