Compliance Specialist 3 (Hybrid Role)
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Job Location:
Mountain View, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Compliance Specialist 3
Job Location: Mountain View CA 94043
Job Duration: 6 months of contract
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- The primary function of this position is to coordinate and support field action related activities. The role requires a general understanding of field action processes and close collaboration with cross-functional teams to ensure accurate processing of customer acknowledgements and timely resolution of inquiries.
- The specialist will also support customer-focused quality initiatives and ensure compliance with record retention and regulatory standards.
Key Responsibilities:
- Process and reconcile customer returned acknowledgement forms in accordance with regulatory requirements and internal procedures.
- Provide guidance and support to customers regarding product recall inquiries.
- Track and report effectiveness metrics for field actions.
- Assist in preparing monthly regulatory reports related to field action effectiveness.
- Provide status updates to cross-functional teams as required.
- Support audit readiness by assisting Audit Management with necessary documentation and compliance activities.
- Assess develop and execute action plans to manage recall communications including handling urgent inquiries.
- Collaborate on the development maintenance and continuous improvement of quality management system processes and procedures.
- Required Qualifications
- Bachelors degree in Engineering Physical Science Biological Science or a related technical field.
- Minimum of 4 years of experience in product quality regulatory compliance or a combination of both within a medical device or regulated industry.
- General understanding of applicable U.S. 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 European regulations RDC Brazil).
- Knowledge of computer system regulations standards and methodologies.
- Strong organizational written and verbal communication skills.
- Demonstrated critical thinking and ability to engage in constructive dialogue.
- Ability to prioritize tasks effectively in a fast-paced dynamic environment.
- Proven ability to collaborate with cross-functional teams and demonstrate appropriate assertiveness.
- Experience working directly with regulatory bodies such as the FDA Notified Bodies or other governmental agencies.
