Regulatory Project Engineer, Senior
Job TitleRegulatory Project Engineer, Senior
In this role, you have the opportunity to
Regulatory Affairs Support for Advanced Innovation New Product Development and Sustaining efforts in both the domestic and international markets for assigned medical devices and consumer products. Provide direct project support for registration and licensing in the US, Canada and EU and indirect support to the International Market groups for all other licensing
You are responsible for
- Quality Culture/Process Improvement – Identify areas for improvement for efficiency and compliance in the internal processes, work instructions, and forms and apply technical expertise to lead process improvement efforts on Hoshin and Improvement teams.
- Training – Maintain technical expertise in core Regulatory functions and secondary Quality functions including all applicable QSPs, WI, Forms, Philips training, and regulatory body requirements. Train and Mentor subordinate Regulatory Personnel. Conduct Business Unit Level Regulatory training for Non-Regulatory personnel.
- Regulatory Proficiency – Maintain expertise in the interpretation of foreign regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned products. Conduct Regulatory Intelligence analysis of foreign markets to identify trends in regulation interpretation and compliance issues
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
- Participates in New Product Development Team discussions with focus on emerging market regulatory submissions
- Tracks, maintains, and communicates schedule of both ongoing and pending international registration activities to Regulatory Affairs Specialists, Project Teams, Regulatory Management and, when necessary, Business Leaders
- Leads Project teams for Regulatory Projects with Business Unit Impact, the development of an executable Quality Plan, coordination with partnering functions/departments/resources and the management of the associated schedule and budget.
- Assists with creation and execution of Regulatory Strategies and Plans for Emerging Markets, including communicating assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
- Participates in routine business reviews to discuss status of registration activities and challenges
- Assists with resolution of international registration issues which may include the creation of explanatory letters or documents
- Directly supports and interfaces Internal and External Quality Audits as a Subject Matter Expert
- Addresses customer related concerns regarding the RA process for our products
- Interfaces with Business Unit functions as needed to resolve regulatory concerns
- Maintains expertise in foreign regulations and standards
- Provides Regulatory Training to business units on regulations and standards as they apply to assigned products / business units.
- Conducts Regulatory Intelligence Analysis on specific assigned regions or content and briefs the business unit Regulatory Teams on results.
- Create and/or lift Regulatory Restrictions based on the Regulatory status
- Responsible for initiating and leading process improvement activities
- B.S. or B.A in engineering or science discipline or equivalent required. Advanced degrees or certifications preferred.
- 6 + years 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.
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