"Alerted.org

In late January, Philips announced that **Bridgefield Capital** signed an agreement to acquire Philips’ Emergency Care business which includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions.

We expect the transaction to close at the end of 2025. With Bridgefield’s support and building on our 40+ year legacy of growth and innovation in emergency medical technology, the Emergency Care business will continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments.

The Director of Global Complaint Management will lead Complaint Management globally for Philips/Bridgefield Capital's Emergency Care (AED/Defibrillator) business, driving value through ensuring end to end operational effectiveness, compliance, team growth and continuous improvement.

Your Role:

+ Provide oversight and leadership of assigned complaint handling and regulatory reporting organizations. Foster a team culture where team members feel valued, listened to, encouraged to grow, and try new things.

+ Drive effective preparation for audits and timely resolution to all audit non-conformances including internal and external. When necessary, partner with legal manufacturing sites, Philips compliance team, and trusted partners to support creation/submission/closure of responses to FDA/Competent Authority observations to ensure a positive outcome for Philips. Communicate with the FDA and other regulators, as needed.

+ Ensure robust dashboards/performance management reports are maintained for each complaint handling organization and that CAPAs are owned/driven to closure with urgency, high quality investigations, with root cause and corrective actions in place. Provide visibility to management and escalation management and resolution, when necessary.

+ Collaborate with leadership in Quality, Medical Affairs, R&D, Service, Manufacturing, OEMs, among others, to ensure timely escalations of critical complaints, and investigations are thorough and timely. Work cross-functionally and in collaboration with other senior leaders within the business and with outsourcing partners develop and lead transformations, performance management and strategic roadmap. Engage with business units on upcoming product launches and ensure resources are budgeted and in place.

+ Member of the Quality Leadership team and support strategic plans/objectives for the Global Complaint Management Organization, as well as developing strategic changes needed to ensure timely & accurate complaints investigation and closure, including on-time regulatory reporting globally.

You're the right fit if:

+ You’ve acquired a minimum of 10 years’ experience in FDA regulated quality/regulatory environments, with a focus on Post Market Surveillance / Complaint Handling / Regulatory Reporting / Quality Operations and a minimum of 7 years’ experience leading/managing teams in a fast paced, high visibility environment. Product experience with AED’s/Defibrillators or other Class III Devices containing medical electrical equipment/software highly desired.

+ You have proven leadership experience delivering on strategic commitments and transformation across various aspects of Quality, with experience in Business/Organizational separations/divestitures highly preferred.

+ You've demonstrated a collaborative customer focus; with high performance behavior of shared accountability, listening and learning, sense of urgency, entrepreneurial, trust and influence management, self-growth, empowerment, and continuous improvement.

+ You have prior FDA and other regulatory audits/inspections experience is required. Experience corresponding to regulatory inquiries associated with regulatory device reporting (i.e. MDR, MDV, etc.) is required

+ You have extensive experience/knowledge of most regulations relative to Post Market Surveillance activities and reporting, such as: ISO 9001/13485/14971, FDA Regulations (21CFR (803, 806, 820, etc.)), MDSAP, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR.

+ You have a minimum of a Bachelor’s degree (required), Advanced 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** **.**

How we work together:

We believe that we are better together than a part. For our **_Office-based_** teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. **This is an Office role.**

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.

+ Learn more about our culture.

Philips Transparency Details:

+ The pay range for this position in Bothell, WA is $172,200 to $275,520.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

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.

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 here.

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 20%.

_\#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