Job Title:  Senior Quality & Regulatory Compliance Specialist

Position Summary

The mission of the STERIS Quality & Regulatory Compliance function is to implement repeatable and sustainable processes to ensure on-going 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.  You will work closely with the STERIS Healthcare business both domestically and internationally to ensure quality standards are being consistently maintained.

*This position is located in Mentor, Ohio and is eligible for a hybrid work schedule. 

What you will do

•    Drive implementation of a Continuous Compliance program for STERIS’s Healthcare facilities, including review of critical areas (e.g., CAPAs, complaints, nonconformances) prior to regulatory inspections to identify areas of improvement.  
•    Lead quality system audits at global facilities.
•    Responsible for preparing data for submission to FDA concerning STERIS product corrections and removals, including identification of affected Customers ensuring current mailing addresses and phone numbers, coordination of Customer notifications, performance of effectiveness checks and final reconciliations, and maintenance of proper documentation.  
•    Responsible for investigating complaints for potential reporting under the FDA Medical Device Reporting 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.
•    Assist manager with the development, enhancement, and standardization of Corporate Quality & Regulatory Compliance processes and their implementation as Corporate policies and procedures; responsibilities include working with and developing strong relationships with key personnel in other critical areas of the organization to develop sound policies and procedures that can be universally applied.
•    Provide support to the 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.  
•    At the direction of the 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.
 

What you need to be successful

•    Bachelors degree with a minimum of two (2) years professional experience with regulatory compliance, quality systems or internal auditing. Healthcare industry experience preferred.
•    In lieu of degree a minimum of eight (8) years professional experience with regulatory compliance, quality systems or internal auditing. Healthcare industry experience preferred.
•    Demonstrated ability to balance multiple high priority responsibilities on-time and effectively. 
•    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.
•    Working knowledge of one or more of the following is a plus: 
      •    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
      •    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

What STERIS Offers

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

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