Markets Quality and Regulatory Specialist at Philips

Remote
Philips

Markets Q&R Specialist

United States of America – Home Based

Full-time

351025

Job Description

You are responsible for

  • Monitors and tracks regulatory communications for timeliness and content
  • Provides review of CA or other external communications to ensure a comprehensive and accurate response
  • Obtain and analyze data as needed for projects and other deliverables.
  • Escalates and consults with Senior Management on complex CA interactions and communications
  • Escalate and consult with team lead or senior colleagues as needed regarding investigations and external responses
  • Support Q&R Management and BIUs by providing high quality project completion and deliverables in support of customer, business and regulatory requirements and metrics.
  • Support Q&R Management and BIUs by providing high quality project completion and deliverables in support of customer, business and regulatory requirements and metrics.
  • Post market support for any compliance requirements.
  • Handles the most complex Vigilance Reporting responsibilities, conducting risk analysis and consulting with senior management on best course of action
  • Utilize complaint investigation, CAPA and other databases/tools to investigate and generate CA and other external responses.
  • Assist in onboarding and training of new employees as requested.

You are a part of

A Quality Team which enables meaningful innovation to our customers by partnering with and guiding the business to achieve world class quality and full regulatory compliance. We do this while creating a great workplace for our people to realize their career aspirations.

To succeed in this role, you should have the following skills and experience

  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
  • BS in technical discipline or equivalent education, experience, training
  • Basic knowledge of QSR, 21 CFR part 803, 820, ISO13485, Med Dev, ISO9001, etc.
  • Good Verbal and written communication skills
  • Ability to query data/analyze data
  • Analytical skill and focus on detail
  • Teamwork in and outside Q&R
  • Provide conflict resolution
  • Utilize creative problem solving techniques.
  • Consistently being available to support our team in meeting all business objectives.
  • Support internal and external audits.
  • Quality and/or Regulatory experience in a medically regulated and technical environment preferred
  • Demonstrated strong organization skills
  • Must be able to work under pressure to meet process/project time frames and company requirements.
  • Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
  • Requires the proven ability to consistently meet and/or exceed goals.
  • Must be capable of making commitments, setting priorities, and delivering results on time.
  • Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

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