Duties:
- 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 or IVD.
- Identify opportunity for regulatory affair processes and drive changes to completion. "
Education, Qualifications, Skills and Experience-
• Bachelor's degree
Typical Job Accountabilities/Responsibilities
- Have working knowledge in EU MDR
- Have working knowledge in Regulatory Change Assessment in
- 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
Company:Prokatchers LLCLocation:Oregon - United StatesJob Types:ContractPost Date:October 28, 2021Valid Through:November 27, 2021