Philips Head of Regulatory Affairs- EMR, CM & Informatics Excellence in Cambridge, Massachusetts
The Head of Global Regulatory Affairs- EMR, CM & Informatics Excellence will have an exciting opportunity to lead the Regulatory Affairs team from product inception through lifecycle management, driving significant innovation, actively providing value-added regulatory affairs guidance and deliverables for new product introductions and product changes across the globe, ensuring Philips EMR, CM and Informatics Excellence products are compliant, safe, and effective, playing an important role in saving lives around the world.
The Head of Regulatory Affairs- EMR, CM & Informatics Excellence is responsible for leading the performance management of the Regulatory Affairs team, using metrics/KPI’s to drive decision making, meaningful actions, and continuous improvement, with a focus on leading strategy and execution of functional excellence to improve performance and increase value of the EMR, CM & Informatics Excellence, regulatory function/BU.
Responsible for leading the development/deployment of innovative Regulatory strategies that facilitate the deployment of multiple function solutions that rely upon partnerships with other Philips businesses as well as 3rd parties to bring products efficiently/compliantly to market and maintain them to support business growth. Providing interpretation of global regulations through the regulatory council and critical input on regulatory risk assessments to support portfolio selection.
Responsible for the hiring and development of critical talent through creating and sustaining robust career & development plans, ongoing coaching/feedback, identifying and addressing gaps in capabilities and competencies. Empower and enable team members to foster a culture of collaboration and confident decision-making when working in cross-functional programs, projects.
Build regulatory capabilities within the EMR, CM & Informatics Excellence BU in areas including Software as a Medical Device (SaMD), clinical decision support software, software using AI, cloud computing, utilization of Software as a Service (SaaS). Partner with other Enterprise Informatics BUs and the Informatics Excellence teams as necessary.
Reporting to the Head of Regulatory Affairs for Innovation & Strategy and Enterprise Informatics you will lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the Business Unit. You will also build proactive, robust, strategic relationships with external stakeholders (FDA, NBs, CAs, MedTech forums etc.) to influence and shape the external regulatory landscape across the domains relevant to the innovation agenda. Will also manage the relationship and efficient flow of information between Business Unit and regional Regulatory Affairs teams.
This role may require travel up to 25%.
You're the right fit if:
You’ve acquired a minimum of 10 years’ experience in Regulatory Affairs within FDA Regulated Medical Device/Software (SiMD/SaMD, SaaS) environments, with a minimum of 5 years’ experience in functional/strategic team leadership/management, to include strategic AOP management to optimize revenue.
Your skills include proven experience and expertise in Global regulatory submissions, risk assessments and standards-FDA 510k, 21CFR part 11, Software- IEC 62304/82304, EU MDR, China, and Health Canada.
You have a minimum of a Bachelor’s Degree in Regulatory Affairs, Regulatory Policy, Quality or similar disciplines. Master’s/MBA degree desired.
You have strong knowledge of Software as a Medical Device (SaMD), clinical decision support software, software using AI, cloud computing, utilization of Software as a Service (SaaS).
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.
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran
- Philips Jobs