Senior Regulatory Affairs Specialist

  • Job Reference: 1108656151-2
  • Date Posted: 8 September 2023
  • Recruiter: LanceSoft, Inc.
  • Location: St Paul, Minnesota
  • Salary: On Application

Job Description

Job Title: Senior Regulatory Affairs Specialist

Location: St. Paul, MN, 55117

Duration: 6 Months

Job Description:

  • Exempt/Non-Exempt: Non-Exempt
  • Years' Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs
  • Have working knowledge in EU MDR
  • Have working knowledge in Regulatory Change Assessment
  • Have working knowledge in US and EU medical device submissions.
  • Have experience supporting internal and external inspections.
  • Work cross-functionally and in a matrixed environment.
  • Have experience with continuous improvement activities.

Education: BA Degree Required

  • This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
  • Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
  • Identify opportunity for regulatory affair processes and drive changes to completion.