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Posted: Friday, May 12, 2017 8:30 AM

Senior Regulatory Affairs Specialist Location: Bothell, WA 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. The Senior Regulatory Affairs Specialist will support regulatory affairs activities at Philips Oral Healthcare Bothell, WA. The RA Specialist will execute activities as defined by the RA Manager and aligned with capabilities; supporting RA operations and administration, systems building, management of personnel and resources, regulatory compliance and global submission activities for all products sold by the Philips Oral Healthcare (Medical Devices, Drugs, and complex Cosmetic Products). 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) and foreign regulatory bodies. Key areas of responsibilities (KARS) for this role include: · Based on business priorities & capabilities, the Regulatory Specialist will provide support for licensing, approbations, registrations (new & renewals), CTDs, PIFs, Technical Files, regulatory administration, labeling, and other assigned projects. · Support systems development and process improvement activities in Regulatory Affairs activities to improve records transparency-organization, compliance, speed, and collaboration, to assure activities are timely meeting needs of the business. · Support preparation and review of registration packages, submission to partners or Competent Authorities; seeking final approval/clearance for new product introductions into any country required by the business. · Collaborate with other functions including Quality Systems, Development, Marketing, Manufacturing & Testing, and Legal to assure coordinated efforts result in desired schedules and timelines for execution of new and revised existing products delivered to the market. · All Specialists will be expected to continue to grow in understanding of the global regulatory frameworks applicable to Philips Oral Healthcare. · Budgeting and management of personnel commensurate with capabilities. · Communication is a major part of this position and requires use of multiple means including telephone, face-to-face individually or in meetings, written memoranda, formal plans, electronic mail and formal presentations to a group. 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. Philips Oral Healthcare creates meaningful innovations that improve people's lives; our Sonicare and Discus products help provide better health and more beautiful smiles across the globe. 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: · A degree in a scientific discipline or equivalent is highly desirable. · RAC Certification and/or a Masters in Biomedical Regulatory Affairs are also desirable. · Must have a minimum of 5 years’ experience in the pharmaceutical, medical device, biotechnology and/or cosmetic (recent) industries. · Candidates should understand the essential framework of regulations and guidelines pertinent to their exposure areas. · Drug, cosmetic, or chemistry experience highly preferred. Alternatively, experience in materials science-based 510(k)s is desirable. · An interest in medical/dental IT Mobile Apps would be desirable. · Must have a basic grounding in GLP, GCP and GMP. · Must have strong interpersonal and communications skills with strong English language ability. · Must be articulate and able to communicate effectively with employees at all levels of the organization, as well as with key individuals outside the organization. These outside contacts may include Philips personnel from commercial organizations, dealers-distributors, and consultants. 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. Contact Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first. Ready to start improving lives by putting your personal skills & passions to work? Apply Today! 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 race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status. #LI-JJ1

Click here for more info: https://philips.taleo.net/careersection/jobdetail.ftl?job=193292&lang=en


• Location: Bothell, Seattle

• Post ID: 30562972 seattle
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