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Posted: Friday, August 25, 2017 2:03 AM

Senior Regulatory Affairs Specialist (In Vitro Diagnostics) 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. This newly formed role provides a unique opportunity to provide strategic regulatory leadership for the Emerging Businesses Business Group (BG). You will lead in the development and application of innovative regulatory strategies for new and transformational “in vitro diagnostics” (IVD) and medical device solutions, supporting all of the Businesses within the EB BG. This role will report to the Head of Quality & Regulatory, Clinical & Medical Affairs for, supporting the development and execution of US-specific regulatory strategy and roadmaps. This role will report to the Head of Quality & Regulatory, Clinical & Medical Affairs for the Emerging Businesses Business Group, and sit on their leadership team. Responsibilities 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: Through strong collaboration with cross-functional teams, responsible for developing and implementing regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy, specifically for the US market, though scope may go beyond US Responsible for US-specific product registrations/approvals. Leads execution of regulatory strategy to ensure timely product registrations in US, regulatory planning for new product introductions and product changes, and in maintaining regulatory compliance. Advises product design teams on US-specific regulatory strategy and requirements for specific new products/solutions. Provides the regulatory plan for US market, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, as needed. 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. When you walk into work you will be joining a truly entrepreneurial team of over 330 employees spread across 8 countries, all passionate about defining the future, growing the business and having fun. You will be considered an “early joiner” to the Philips Emerging Businesses family which plans to expand itself by approximately 1000 members in the next 3 years. The businesses are all tackling unmet medical needs through innovative solutions, including DPS, Handheld Diagnostics, Home Clinical Monitoring, Biocell and Light & Health. These businesses are developing transformational technologies, often requiring new regulations and new methodologies, which make this an exciting and challenging space. Location: The position will be part of the Philips Emerging Businesses group. It is a remote, home-based position. This person must be based on the East Coast. 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: Master’s or PhD degree Proven track record in successful clearance / approvals with FDA, ideally with Medical Device and In Vitro Diagnostic experience Strategic thinker, with strong business acumen and demonstrated experience with business processes Practical knowledge of US standards and regulations. Viewed as an expert by the company and in the field Minimum of ten years of related experience Strong influential and communication skills Track record to collaborate effectively in cross departmental teams, e.g. Product Development, marketing, operations team, and external partners Ability to deal with changing priorities Team player who is able to work in a flexible and goal oriented environment Structured way of working Pragmatic hands-on mentality 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. Call to Action / Contact 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 of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #LI-AH1

Click here for more info: https://philips.taleo.net/careersection/jobdetail.ftl?job=211096&lang=en


• Location: District Of Columbia, Washington

• Post ID: 32663703 dc
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