Quality & Regulatory Compliance Specialist

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

This is an entry-level position. The mission of the STERIS Quality & Regulatory 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. 

 

The 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.   

 

This position is based in Mentor, Ohio and requires time in the office. 

 

Duties

Product Corrections and Removals

• Responsible for assembling product and Customer data concerning product corrections, removals and field upgrades, tracking of Customer notifications and Field Service repairs, and maintenance of correction documentation.

Medical Device Reporting

• Responsible for investigating complaints for potential reporting under the FDA Medical Device Reporting regulations, preparing draft complaint summaries and MDR reports for presentation to the Reportable Events Committee for review and maintaining documentation in accordance with department policies, procedures, and work instructions.  

Internal Quality Audits

• Provide support to the Director, Quality & Regulatory Compliance in the development, enhancement, standardization, execution and implementation of processes to manage the notified body audit program.  Support includes coordination of facility audit scheduling and issue resolution.  
• Support execution of the supplier quality program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests and as necessary, issue resolution. 
•  Participate in quality system audits at global facilities as requested.  

Observation Follow-up

• Provide support to the Quality & Regulatory Compliance team in the investigation and resolution of global CAPAs.
• At the direction of the Director, Quality and Regulatory Compliance, support FDA and other regulatory agency responses following receipt of formal observations.
• Track corrective action activities for external audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments.

Duties Continued

The Quality & Regulatory Compliance Specialist will develop a firm working knowledge of the following regulations and standards:

• 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
• 21 CFR Part 803 – Medical Device Reporting
• 21 CFR Part 806 – Medical Device Corrections and Removals
• 21 CFR Part 7 – Enforcement Policy, Subpart C – Recalls
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
• 21 CFR Part 11 – Electronic Records, Electronic Signatures
• ISO 13485 Medical devices – Quality management systems
• ISO 9001 Quality management systems – Requirements
• EN ISO 11135-1 Sterilization of healthcare products – Ethylene Oxide
• EN ISO 11137-1 Sterilization of healthcare products – Radiation
• ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
• ISO 14971 Application of Risk Management to Medical Devices
• EU Medical Device Directive
• EU Medical Device Regulation
• EU MEDDEV 2 12-1: Guidelines on a Medical Device Vigilance System
• UK Medical Devices Regulations 2002

 

Required Experience / Education

• Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration.  
• No prior specific experience is required as this is an entry-level position.
• Excellent PC skills, including Microsoft Office applications.

 

• 10% domestic travel. Estimated to 5 weeks per year. International travel may also be required.

 

Skills

• Self-starter that is highly organized.
• Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implem