Job Description
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. They are seeking a Quality & Regulatory Compliance Specialist to implement sustainable processes ensuring compliance with regulations and standards, while collaborating with various stakeholders and supporting quality management functions. 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 Skills 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 1+ years business experience Experience with risk management is helpful but not required Bilingual skills are a plus, but not required Benefits Market Competitive Pay Extensive Paid Time Off and (9) added Holidays Excellent Healthcare, Dental and Vision Benefits Long/Short Term Disability Coverage 401(k) with a company match Maternity and Paternity Leave Additional add-on benefits/discounts for programs such as Pet Insurance Tuition Reimbursement and continued education programs Excellent opportunities for advancement in a stable long-term care Company Overview STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers. It was founded in 1985, and is headquartered in Mentor, Ohio, USA, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship STERIS has a track record of offering H1B sponsorships, with 4 in 2026, 26 in 2025, 28 in 2024, 15 in 2023, 33 in 2022, 18 in 2021, 19 in 2020. Please note that this does not guarantee sponsorship for this specific role.