Philips Clinical Project Manager in Bothell, Washington
In this role, you have the opportunity to:
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.
You are responsible for
Provides support for the operation of clinical trials and product approvals in the USA, EU and ROW. Obtains approval to conduct clinical trials of investigational equipment.
Identifies and prepares clinical trial documentation (Protocol, Investigator Brochure, Consent Form, and Case Report Form) to obtain product approval and reimbursement classification for new products and therapies.
Develops documentation and obtains Competent Authority approval and Ethics approval for non-CE marked product in the European Union.
Develops IDE (Investigational Device Exemption), IRB (Institutional Review Board), 510(k) (Pre- Market Notification), and PMA (Pre-Market Approval) and Panel meeting documentation and receives approval to conduct clinical trial (IDE, IRB) or release device for sale (510(k), PMA).
Organizes, executes and submits results of post marketing surveillance studies as mandated by FDA.
You are a part of
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.
To succeed in this role, you should have the following skills and experience
7+ years of progressively successful experience in Regulatory Affairs.
BS Degree in Science, or equivalent.
Previous Class I/Class II Medical Device experience
Previous FDA submission and clinical trial experience.
Working knowledge of FDA and ISO Regulations.
Global product knowledge, re: clinical applications for imaging technologies.
Experience in clinical trials and development of clinical protocols and investigations.
Problem solving skills for regulatory, quality and safety issues.
FDA PMA submissions and management experience.
In return, we offer you
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).
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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.