Clinical/Nursing Compliance Specialist
Job TitleClinical/Nursing Compliance Specialist
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
In this role, you will evaluate, investigate, track and complete complaints through effective and established complaint handling process. In addition, you will ensure accurate documentation of evaluation and investigation results with the assigned complaint records. Lastly, you will participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
Key areas of responsibilities (KARS) for this role include:
- Evaluate, investigate, track and complete complaints through effective and established complaint handling process.
- Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
- Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings.
- Collaborate with Engineering, Customer Support, Field personnel, Market Service Order reviewers and other appropriate groups for adequate initial evaluation of complaints.
- Collaborate with Adverse Event Coordinators for reportable complaints as well as Product Safety Committees for Correction and Removal process.
- Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data gets pushed to the appropriate departments for actions.
- Support reviews and audits assigned.
- Perform other duties as assigned.
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
You will report directly to the Quality Assurance Manager in Philips Emergency Care & Resucitation (ECR) Business Innovation Unit (BIU). The ECR team is part of Philips Patient Care & Monitoring Solutions (PCMS) division. This position is based in Bothell, WA.
Location: This position is based in Bothell, WA.
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
- 3-5 years of experience in a medically regulated and technical environment.
- Registered nurse or engineering discipline or equivalent education, clinical experience, training.
- Demonstrated strong results orientation.
- Proficiency using statistical tools, office tools, and various other computer software applications.
- Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
- Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
- Requires the proven ability to consistently meet and/or exceed goals. Must be capable of making commitments, setting priorities, and delivering results on time.
- Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Find out more info about Philips at www.philips.com/na/careers.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.
In case of difficulties with your job application please send an email to [email protected]
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