Home > Boston jobs > Boston management/professional

Posted: Monday, October 23, 2017 9:38 PM

Regulatory Affairs Program Manager- EU MDR 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. In this role you will Manage the EU MDR (European Union Medical Device Regulation) Project across Philips: · Develop Project Planning Tools for Review and Approval of timeline, content and responsibilities by the steering committee and sponsors. · Develop regular status reporting and communication tools for Steering Committee and Sponsors · Develop and deploy planning tools, RACI Charts and status reports with focus on deliverables for task forces · Provides business management with program performance status, variances to plan and identification of corrective actions. 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: · Coordination of timeline and deliverables across the task forces · Coordinate with the technical leads · Develop with the technical leads opportunities to work collaboratively externally with regulators, trade groups, customers, and other stakeholders regarding the development, review, and update of standards, guidances, whitepapers, and policies needed to resolve current issues and optimize current or emerging technologies · Build and maintain the program organization, chose the ways of working and define the interfaces with other functions. Knows and applies the guidelines set forth by the sponsors and steering committee · Manage the training programs and resource utilization to support information sharing sessions as well as post process release detailed training activities – Develop Knowledge Center for on-going post program/project completion. · Manage escalations from businesses, functions, task forces to Steering Committee · Manage records and general information (e.g.; SharePoint and/or intranet · Provide leadership direction to personnel on where to located information or resources in understanding, interpretation and implementation of EU MDR and associated MEDDEVs. · Partner with technical leads on leading the teams within the businesses in defining plan(s) for implementation and ensure process defined to identify required performance standards for Philips · Needs to be able to work across functions and sites as well as work with the Philips End to End (E2E) Process Improvement Initiative’s Business Process Owners to ensure alignment of regulations and processes · Needs to be able to manage up to 15 work stream projects concurrently – milestones, resources, budget, conflicts (Multi-site, cross function programs) 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. This role reports to the Q&R leader for Regulatory Standards. In this team we: · Are committed to fully satisfy the needs of our customers by delivering high quality medical devices, solutions, and services · Fully satisfy the needs of our customers. o We adapt to changing markets to ensure we continually meet the needs of our customers. o We consider our customers' perspectives by delivering effective, safe and reliable products through our business processes. o We ensure speed of action, execute rigorously, and see things through to meet customer needs, when the customer needs it, and where the customer needs it. · Deliver high quality medical devices, solutions, and services. o We continuously and systematically learn, improve, and develop to ensure we achieve substantial compliance with all applicable quality systems and regulatory requirements. o We collaborate and leverage each other to deliver high quality devices, solutions, and services to our customers, enabling them to achieve clinical excellence. 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: · Bachelor’s degree required in science or engineering fields. Master’s preferred. · Familiarity with global medical device regulations, requirements, and standards to support process planning and resource designation · Knowledge and experience in use of project management methods and tools · Program and Project Management experience (Certification required) · Familiar with developing planning and monitoring techniques of resource and budget needs and utilization · Good understanding of business roadmap – Understand potential conflicting or colliding projects (business unit specific as well as Philips wide) · Good understanding of quality system regulations and processes · Proven communication and conflict resolution skills · Proven ability to lead cross-functional, diverse teams with competing goals · Strong international cultural awareness · Strong ability to influence without authority (internal and external) · Strong writing and cognitive skills · 10+ years of experience · Approximately 3 year assignment reporting into Head of Global Regulations and Standards 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. 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 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-AV1

Click here for more info:

• Location: Andover, Boston

• Post ID: 35975426 boston is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017