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Director of Regulatory Affairs

3 months ago

Orange, United States Philips Full time
JOB DESCRIPTION

Job Title

Director of Regulatory Affairs & Quality

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 be provided for this position. For this position, you must reside in 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 .  US work authorization is a precondition of employment . The company 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.

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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 .

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.

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 . 

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. 

#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.