Job Title:  Quality & Regulatory Compliance Specialist

Position Summary

This position is located onsite in Mentor, Ohio with opportunity for a hybrid work schedule.

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 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 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

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.    
 

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.  
• Provide support to Quality & Regulatory Compliance management 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.  
• Responsible for monitoring the Regulatory Compliance email inbox and incoming mail for new events and MDR correspondence from FDA, preparing the agenda and assembling the documentation of potential reportable events for review by the Reportable Events Committee; submitting electronic MDR reports to FDA.
• 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.  
• Provide support to the Quality & Regulatory Compliance team in the investigation and resolution of global CAPAs.
• At the direction of Quality & Regulatory Compliance management, 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.

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Required Experience

•    Bachelor's Degree required 

•    Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.

•    Protect company confidential information by properly storing, retrieving, and disseminating such information only to those authorized.

•    Perform data analysis/trending as requested.  

•    Support continuous improvement efforts within the facility and the organization through participating in quality and performance improvement projects as requested.  

•    Conduct daily activities of assigned job responsibilities and projects as assigned.

•    Support a safe, clean, and secure working environment by supporting procedures, rules, and regulations.
 

Preferred Experience

•    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 implementation of corrective actions; able to work effectively and professionally with external people including Customers and government officials.

•    Strong oral and written communication skills.

•    Ability to balance multiple high priority responsibilities on-time and effectively.

•    Ability to perform assigned tasks in a highly complex environment.      

•    Excellent PC skills, including Microsoft Office applications.