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Quality & Regulatory Compliance Specialist

STERIS
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Quality & Regulatory Compliance Auditing 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.  

 

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.    

 

Location

This is a hybrid role based in STERIS’ Corporate Offices in Mentor, Ohio. In order to support the business needs working a minimum of 3 days a week in the Mentor office is expected.

 

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

 

What you'll do as a Quality & Regulatory Compliance Auditing Specialist

  • 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 Approved/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 and readiness activities at global facilities as requested.  
  • Provide support to the Quality & Regulatory Compliance team in the investigation and resolution of global Corrective Action and Preventive Actions (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.
  • Support STERIS’s participation in the FDA’s Case for Quality program as requested.
  • Provide support to the Quality Operations team in supporting key objectives, trending, and process improvement.

 

The Experience, Skills and Abilities Needed

Required:

  • Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration.  
  • Excellent PC skills, including Microsoft Office applications, and use of AI tools is required.
  • This is an entry-level position.
  • Must be willing to travel domestically & internationally.

Preferred:

  • 1+ years business experience.
  • Experience with risk management is helpful but not required.
  • Bilingual skills are a plus, but not 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 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.

 

 

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 – Quality Management System Regulation (QMSR)
  • 21 CFR Part 803 – Medical Device Reporting
  • 21 CFR Part 806 – Reports of 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
  • UK Medical Devices Regulations 2002