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Regulatory Affairs Specialist

Company: Rangam Consultants Inc.
Location: Pleasanton
Posted on: January 25, 2023

Job Description:

Term & Start

---12-18 month--- Start ASAP--- Location: Pleasanton, CA

Title: Senior Regulatory Affairs Specialist

The contingent worker should be a self-starter, requiring minimum supervision on dailyactivities. He/She should have hands on experience in the review/approval of change orders in PLM (e.g. Agile or Windchill), labeling changes and labeling requirement assessment, and other routine regulatory tasks.

  • Provide regulatory support for Rebranding, Labeling and Packaging Update Projects for Heart Failure products
  • Initiate, Review and Approve Change Orders related to various assigned Projects
  • Communicate with International Regulatory Affairs affiliates and provide adequate information for initiating Regulatory Assessments
  • Navigate and provide regulatory input to the develop approaches for Packaging and labeling updates
  • Supports a collaborative environment to align with other cross functional individuals
  • Active follow-up on the progression of day-to-day documentation activities required to successfully and timely complete the deliverables
  • Supports the Technical Publications team to update Labels and IFUs and align with the requirements
  • Supports the Packaging team to update Packaging design and drawings and align with the requirements
  • Stay abreast of all pertinent regulatory affairs/ quality system issues specific to projects
  • Applies skill set to navigate through the various regulatory operations activities as necessaryMandatory Requirements
    • Medical Device Regulatory Affairs (2+ years)
    • B.S. in Engineering or Life sciences or an alternative Bachelor's degree program with experience in Engineering or Life Sciences
    • A Masters degree in Regulatory Affairs can substitute for years of experience
    • Cross functional understanding of Design Control, Packaging, Labeling, Risk Management, Clinical Affairs as required to support RA submissions

      About Rangam:
      Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
      Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities.

Keywords: Rangam Consultants Inc., Pleasanton , Regulatory Affairs Specialist, Other , Pleasanton, California

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