Regulatory Compliance Specialist

2 weeks ago


Bishop's Stortford, Hertfordshire, United Kingdom STERIS Full time

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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