Regulatory Science Specialist

3 weeks ago


Fremont, California, United States iMPact Business Group Full time
Job Overview

We are seeking a highly skilled Regulatory Science Technician to join our team at iMPact Business Group. As a key member of our team, you will be responsible for assisting in the development and validation of testing methodologies used to control raw materials, production intermediates, and final products.

Key Responsibilities:

  • Develop and validate testing methodologies to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to establish and document new or existing compound identification methods.
  • Conduct analytical testing of samples to ensure quality and regulatory compliance.
  • Provide analysis and evaluation of materials and products throughout the development process.
  • Operate and maintain various analytical instruments, including FTIR spectroscopy, ICP-MS, XRF, and UV-Vis spectroscopy.

Requirements:

  • Bachelor's degree in Life Sciences, Engineering, or a related field.
  • 3+ years of experience in regulatory affairs, quality assurance, or a related field in the medical device or healthcare industry.
  • Strong understanding of FDA, ISO, and other applicable regulatory requirements for medical devices.
  • Excellent attention to detail, organizational skills, and ability to manage multiple projects.
  • Ability to work independently and collaboratively within a team.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.

About iMPact Business Group:

iMPact Business Group is a leading provider of staffing solutions for businesses in the medical device and healthcare industries. We are committed to delivering exceptional service and results to our clients and candidates.



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