Regulatory Affairs Consultant
Company: Philips
Location: Somerville
Posted on: June 16, 2022
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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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