Compliance Administrator

Job Title: Compliance Administrator
Location: Sunnyvale, CA
Type: Contract
Compensation: $25.00 - $30.00
Work Model: Hybrid


Overview

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)

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific