Regulatory Affairs Operations Specialist

Your challenge
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.
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:
+ Managing the FDA establishment registrations and device listings process for all Philips facilities. Providing input to management regarding Philips-wide establishment registration strategy.
+ Managing the medical device manufacturer/distributor US state licensing process for Philips facilities.
+ Owning the FDA Certificates to Foreign Government and embassy authentication submission strategy and execution for all Philips businesses.
+ Owning and maintaining the regulatory deliverables database across all Philips businesses, creating a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals.
+ Owning and maintaining department procedures related to the above responsibilities
+ Notarizing regulatory documents.
Your team
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 Director of Regulatory Compliance & Communications
Location : Andover, MA
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.
Specific skill requirements for this role include:
Education & Training:
+ Bachelor?s degree in a related technical or business discipline.
+ A minimum of 3 years related experience in the medical device industry.
+ Working knowledge of FDA medical device regulations. Experience with FDA establishment registration and/or Certificate to Foreign Government applications desirable.
+ Familiarity with managing Microsoft SharePoint sites.
+ Demonstrated ability to effectively interact with employees and managers on all levels.
+ Goal-oriented and proactive in problem solving.
+ Strong written and verbal communication skills.
+ Attention to detail.
+ Must be able to perform responsibilities with minimal supervision.
Our offer
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 our more information about Philips at
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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