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Regulatory Affairs Specialist Jobs

Company

Intellectt Inc
Address Plymouth, MN, United States
Employment type CONTRACTOR
Salary
Category Medical Equipment Manufacturing,Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-06-14
Posted at 1 year ago
Job Description

Role: Senior Regulatory Affairs Specialist

Location: Plymouth, MN - 55442

Duration: 12 Months on W2

Duties:

  • Have working knowledge in Regulatory Change Assessments
  • This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
  • Have experience supporting internal and external inspections
  • Identify opportunity for regulatory affair processes and drive changes to completion.
  • Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
  • Have working knowledge in US and EU medical device submissions
  • 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.
  • Have working knowledge in EU MDR
  • Have experience with continuous improvement activities
  • Work cross-functionally and in a matrixed environment

Education and Years Experience:

  • BA Degree Required and 2-4 years of experiences in Medical Device Regulatory Affairs