Quality & Regulatory Compliance Specialist

Steris Corporation•Mentor, OH

60d•Hybrid

About The Position

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.

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.
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.

Responsibilities

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 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.