Director of Regulatory Affairs & Quality

at Philips in Rosemont, Illinois, United States

Job Description

The Director of Regulatory Affairs & Quality will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities.

Your role:

+ Leading Regulatory Affairs strategy end-to-end execution (product inception through to lifecycle management), driving innovation, actively providing value-added regulatory affairs input and deliverables for new product introductions and product changes.

+ Use metrics and key performance indicators to drive regulatory and quality decision making, meaningful actions, and continuous improvement.

+ Lead the development and execution of regulatory and quality strategies to maintain current products and bring new products to the market in an efficient manner.

+ Develop and deploy regulatory and quality resources in an efficient and effective manner.

+ Represent regulatory affairs and quality on the management team. Be able to articulate compliant regulatory and quality strategy as well as manage operational matters such as Annual Operating Plan (AOP) development.

+ Provide practical interpretation/guidance of regulations, standards and input including risk assessment to support business decision making.

+ 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 business unit innovation agenda.

+ Will manage, oversee, hire and develop talent within the Regulatory Affairs and Quality teams through creating and sustaining robust career & development plans, ongoing coaching and feedback, and identifying and addressing gaps in capabilities and competencies.

+ Proactively build regulatory and quality capabilities within the business.

+ Empower and enable regulatory affairs and quality team members to foster a culture of collaboration and confident decision-making when working in cross-functional programs and projects.

+ Manage/oversee execution of inspection readiness activities, including active inspection support.

+ Participate in the coordination and execution of the internal audit program.

+ Track and prepare GXP internal and external metric reports periodically, including annual review with the Leadership team.

+ Manage/oversee recall efforts, compliant handling, failure investigation, and adverse event reporting.

+ Support the planning, design, and implementation of commercial readiness initiatives.

+ Management, maintenance, and evaluation of the Quality Management System and processes for optimization and continuous improvement.

+ Ensure compliance with regulatory requirements and internal procedures.

+ Author and implement QA GXP standard operating procedures.

+ Reporting to the Business Leader, you will lead and enable strong cross-functional partnerships with key stakeholders including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the Business Unit.

+ This Hybrid based role may require travel up to 10%.

+ Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN or Cambridge, MA or Rosemont, IL or Bothell, WA or Pittsburgh, PA or Orange, OH or San Diego, CA or Nashville, TN.

You’re the right fit if:

+ You have a minimum of 10 years’ experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical Device industry, including 3 years’ experience and a strong track record in successfully leading/managing Regulatory Affairs and/or Quality teams.

+ You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485, ISO 14971, 21 CFR 820, etc.)

+ You have a proven track record leading cross-functional/diverse teams in a matrix organization, with challenging goals, with experience working in smaller companies desired.

+ You’re experienced in building/fostering strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities).

+ You have a minimum of a Bachelor’s Degree (Required) in Engineering, Life Sciences, Quality, Regulatory or comparable disciplines.

+ You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .

+ 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 (https://www.philips.com/a-w/about.html) .

+ Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)

+ Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)

+ Read more about our employee benefits (https://www.careers.philips.com/na/en/best-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 (https://www.careers.philips.com/global/en/diversity-and-inclusion) .

Philips Transparency Details:

The pay range for this position is $137,000 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.

\#LI-PH1

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