Regulatory Affairs Specialist I

  • Integrated Resources, Inc
  • Chaska, Minnesota
  • 01/24/2021
Full time

Job Description

Job Title: Regulatory Affairs Specialist I

Duration: 5 Months (Contract with high possible ext.)
Location: Chaska MN 55318


Job Description:
  • Plans, coordinates, facilitates, and reports on Industry regulatory programs.

Responsibilities may include:
  • Administration of the companies complaint management program for compliance to corporate requirements
  • Assist in the planning and implementing pre-market registration, reporting and compliance activities in accordance with the business plans.
  • Assists in the implementation of global regulatory compliance programs for product corrective action and/or adverse event reporting.
  • Assist in the preparation of premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.

Educational requirements:
  • Bachelor's degree in field with 2+ years exp. OR Master's degree in field with 1+ years exp.
  • IVD experience strongly desire.