Quality & Regulatory Compliance Specialist

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

Company H1B Sponsorship