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Regulatory Affairs Consultant

Company: Philips
Location: Somerville
Posted on: June 16, 2022

Job Description:

Post Market Surveillance (Randstad Contingent Worker) Actual Job Title - Post Market Risk Management EngineerThis position will be fully remote and can be home-based from anywhere in the US, with a preference for alignment to EST work hours. In this role, you will have the opportunity to:Be a key analyst in the expanding Quality & Regulatory Risk Management team. You will be responsible for:Performs, safety risk assessments and evaluates and estimates risk as part of post market surveillance in support of complaint investigations, field corrective actions, engineering changes, product life cycle sustaining efforts, and supplier risk assessment evaluation and manufacturing non conformances.Conducts Health Hazard Analysis, Risk Estimation/Risk Evaluation on post market issues that are derived from Complaints, Customer feedback, MDRs, AER, Incident reports, SCARS, new trends exceeding predetermined thresholds, newly identified hazards and hazard situations and more.Collaborates with cross functional post risk management team to ensure completion of the Issue Impact Assessment. Presents findings to Corrections and Removal Board recommends in conjunction with the business, actions for potential recalls.Supports the organizations risk management goals, strategies and processes. Manages post market updates to Risk Management Matrix and or Safety Risk Analysis file.Develops extensive product knowledge of all devices supported by HPM. Applies BXM method Provides feedback to preproduction risk management to add veracity to the preproduction predictions and estimations of the risk of the medical device. Provided evidence of new Hazards that were not previously foreseen and help determine of P1 and P2 estimations are still valid.Supports regulatory audits as SME Advises R & D of the outcome of post market safety risk analysis Keeps abreast of emerging trends or regulatory changes for risk analysisTo succeed in this role, you should have the following:BS Degree is Engineering, Life Sciences, or related Technical Field required2-5 Years experience in Risk Management and Safety Assessments for Medical DevicesExperience & Knowledge of ISO 14971 - Risk Management requiredExperience Managing Risk Management FilesExperience developing and managing Risk Management PlansMedical device pre-market and/or post-market risk analysis experienceExperience with Complaint records and hazard analysisYou will be a part of:An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people's lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.In return, we offer you:Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.Quality is 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, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities 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.Why work on a project at Philips?If you're looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you'll find all that and more with project work at Philips.The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.

Keywords: Philips, Somerville , Regulatory Affairs Consultant, Professions , Somerville, Massachusetts

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