Regulatory Compliance Specialist
2 weeks ago
At STERIS, we strive to create a healthier and safer world by providing innovative products and services that support patient care with an emphasis on infection prevention.
**About the Opportunity:**
We are seeking a highly skilled Regulatory Compliance Specialist to join our team in ensuring adherence to regulatory standards such as ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and others. As a key member of our Quality team, you will be responsible for coordinating document control transactions, site record retention, calibration, and inspection activities.
**Key Responsibilities:**
- Complete document control transactions to ensure accuracy and timeliness.
- Investigate customer complaints and maintain complaint documentation.
- Facilitate Corrective Action Preventative Actions (CAPAs) and Non-Conforming Records (NCRs).
- Review Design History Files (DHRs) and support batch record release.
- Maintain site record retention practices.
- Coordinate site calibration activities and recordkeeping.
- Support site inspections and recordkeeping.
- Assist with internal and external audits.
- Collaborate with suppliers and customers on quality assessments.
- Analyze and track site quality data.
**Required Skills and Qualifications:**
To succeed in this role, you should have at least two years of experience in a regulated industry, specifically in areas such as:
- Customer complaint investigations.
- Audit coordination.
- CAPA and NCR investigations.
- Risk management.
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