Senior Regulatory Affairs Engineer
Senior Regulatory Affairs Engineer
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 will work as a Regulatory Affairs Engineer on problems of diverse scope where analysis of regulatory data requires evaluation of identifiable factors. The development of the solution requires a multi-disciplinary approach and knowledge of regulatory principles, theories and concepts.
You are responsible for
- Supports and provides regulatory expertise to assigned medical devices and consumer product development projects from initial kickoff to post marketing phase.
- Creation and execution of complex Regulatory Strategies and Plans for assigned medical devices and consumer products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.
- Develops the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released.
- Prepares and submits US FDA pre-sub, 510(k), and other product submissions according to FDA guidelines.
- Creates EU Technical File and Declaration of Conformity documents (MDD, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines.
- Maintains expertise in domestic and international regulations and standards, with a focus on assigned medical devices and regional focus on the US (FDA), EU (MDD), and CA (Health Canada).
- Support the international regulatory specialist team with inputs, as needed, into the registration packages they prepare.
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
- Formulates the solution for (technical) partial problems that cannot be found by combining previous experiences but by composing newly acquired regulatory knowledge.
- May lead multi-disciplinary regulatory change projects, managing a number of people. Works independently and provides consultative advice within specific functional regulatory areas.
- Introduces regulatory methods/procedures that are new for the organization. Applies advanced regulatory process principles to multiple tasks.
- Proficient in regulatory area of specialization and contributes in other disciplines. Determines feasibility of regulatory concepts or projects. Has basic knowledge of related disciplines.
- Bachelor's degree with 5+ years of related experience in regulatory affairs engineering; or a Master's degree with 3+ years of related experience in regulatory affairs engineering.
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.
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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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