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Regulatory Affairs Specialist II

2 months ago


Minneapolis, Minnesota, United States Randstad Full time
Job Summary:

We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Randstad. As a key member of our life sciences team, you will be responsible for ensuring compliance with regulatory requirements and providing expert guidance on regulatory strategies.

As a Regulatory Affairs Specialist II, you will be responsible for:

  • Supporting daily Regulatory Affairs functions, including compliance with 21 CFR 820, 807, and 803, as well as ISO 13485 requirements.
  • Providing regulatory support in Manufacturing Plant Transition Projects and Quarterly Management Reviews.
  • Developing and maintaining global regulatory strategies.
  • Maintaining positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements:

  • Bachelor's degree in a relevant field.
  • Currently pursuing or have a Master's degree in Regulatory Affairs.
  • 4 years of experience in Regulatory Affairs.
  • Strong leadership skills and ability to work effectively within a team.

Benefits:

  • Competitive salary and benefits package.
  • Opportunity to work with a leading staffing and recruitment agency.
  • Chance to develop and grow in the life sciences arena.

Equal Opportunity Employer:

Randstad is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment.