Regulatory Affairs & Quality Compliance Specialist - Eden Prairie, MN, US, 55344

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The mission of the STERIS Regulatory Affairs & Quality Compliance function is to implement repeatable and sustainable processes to ensure ongoing compliance with domestic and international regulations and standards.  This includes evaluating the relevance to all STERIS facilities and products and implementing efficient and effective processes to ensure adherence to applicable regulations and standards.  

This position is a fully remote role. 

The Quality & Regulatory Compliance Specialist will develop a firm working knowledge of regulations and standards applicable to the business including, but not limited to: 

• 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
• 21 CFR Part 11 – Electronic Records, Electronic Signatures
• ISO 13485 Medical devices – Quality management systems
• EU Medical Device Regulation 2017/745

The regulatory and compliance activities require close work with STERIS corporate domestic and international staff and Customers and U.S and foreign government agencies.  The Quality & Regulatory Compliance Specialist will have responsibility for performing the duties of the functional compliance areas described below under the guidance and direction of his/her manager and other senior Quality & Regulatory Compliance staff.    
 

Duties

• Responsible for assembling product and Customer data concerning product corrections and removals, tracking of Customer notifications and Field Service repairs, and maintenance of correction documentation.
• Responsible for investigating and managing complaints for potential reporting under the FDA Medical Device Reporting regulations and applicable international regulations, preparing draft complaint summaries and MDR/Vigilance reports for presentation to the Reportable Events Committee for review, and maintaining documentation in accordance with department policies, procedures, and work instructions. …