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System One Holdings, LLC
Compliance AdministratorSystem One Holdings, LLC • Sunnyvale, CA, United States
Compliance Administrator

Compliance Administrator

System One Holdings, LLC • Sunnyvale, CA, United States
16 hours ago
Job type
  • Full-time
Job description

Compliance Administrator

Established Medical Device company is looking to hire a Compliance Administrator to assist their field action team with ensuring appropriate processing of customer acknowledgement forms and inquiries related to field actions. Must bring experience with recalls and field action compliance.

Responsibilities

  • Coordinate and assist the field action team with related activities to ensure proper processing of customer acknowledgment forms and inquiries.
  • Collaborate with business partners, management, and the field action team to address customer escalation concerns related to field actions.
  • Process and reconcile customer returned acknowledgment forms in compliance with regulations and internal procedures.
  • Provide guidance to customers regarding product recall questions and update on the effectiveness levels of each field action.
  • Assist in preparing monthly regulatory reports on field action effectiveness status.
  • Manage the recalls inbox, complete requests, and provide status updates to cross-functional teams as needed.
  • Support audit readiness by assisting with information and assessments required for internal and external audits.
  • Develop and improve processes and procedures within the quality management system to enhance operational efficiency.

Requirements

  • Minimum Bachelor Degree BS degree in Engineering, Physical or Biological Science, or other technical field
  • Minimum 4 plus years' experience in product quality or regulatory compliance within the medical device or other regulated industry
  • General understanding of applicable US medical device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO 14971), and international regulations (e.g., CMDR Canada, European, RDC Brazil)
  • Experience with computer regulations/standards and methodologies
  • Strong organizational, written, and verbal communication skills; plus critical thinking skills and proficiency in constructive dialogue
  • Effective at prioritizing tasks within a fast-paced, dynamic environment
  • Experience working directly with the FDA, Notified Body, or other governmental agencies (preferred)
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Compliance Administrator • Sunnyvale, CA, United States

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