Quality & Regulatory Compliance Specialist

STERIS Corporation•Mentor, OH

2d•$58,100 - $62,000•Hybrid

About The Position

This is an entry-level position within the STERIS Quality & Regulatory Compliance function. The primary mission is to implement repeatable and sustainable processes to ensure ongoing compliance with domestic and international regulations and standards. This involves evaluating the relevance of these regulations to all STERIS facilities and products and implementing efficient and effective processes to ensure adherence. Compliance activities require close collaboration with STERIS corporate domestic and international staff, Customers, and U.S. and foreign government agencies. The Quality & Regulatory Compliance Specialist will be responsible for performing duties within functional compliance areas under the guidance of management and senior staff. STERIS Applied Sterilization Technologies (AST) provides contract sterilization, laboratory testing, and product and packaging testing services to medical device and pharmaceutical manufacturers.

Requirements

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.

Nice To Haves

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

Responsibilities

Investigating and managing complaints for potential reporting under 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.
Maintaining documentation in accordance with department policies, procedures, and work instructions.
Providing support to Quality & Regulatory Compliance management in the development, enhancement, standardization, execution, and implementation of processes to manage the Approved/Notified Body audit program.
Coordinating facility audit scheduling and issue resolution.
Supporting the execution of the supplier quality program, including qualifications and/or audits, routine monitoring, assessment meetings, action requests, and issue resolution.
Participating in quality system audits and readiness activities at global facilities as requested.
Providing support to the Quality & Regulatory Compliance team in the investigation and resolution of global CAPAs.
Supporting FDA and other regulatory agency responses following receipt of formal observations, at the direction of Quality & Regulatory Compliance management.
Tracking corrective action activities for external audit observations and obtaining and reviewing objective evidence as actions are completed in accordance with prescribed commitments.
Supporting STERIS’s participation in the FDA’s Case for Quality program as requested.
Providing support to the Quality Operations team in supporting key objectives, trending, and process improvement.