Regulatory Compliance Associate - 1584

Location: Southern CA

Responsible for the maintenance of the Complaint and CAPA systems. Maintains the Internal Audit system. Monitors and improves device reporting and tracking/control systems. Participates and performs internal and external Quality System audits. Ensures CAPA, Internal Audits and Customer Complaint data is accurate and collected in a timely manner. Responsible for the reporting and trending of CAPA, Internal Audits and Customer Complaint data. Assists in and performs quality systems training to Company team members. SKILLS: B.S. Degree in life sciences or related field.  Minimum 3 years experience in the medical device regulatory field.  Class III medical device regulatory field preferred. Demonstrated knowledge of Quality System requirements and FDA and/or International product requirements. Highly knowledgeable in worldwide regulatory requirements (i.e. FDA regulations 21 CFR 50,54, 801, 803, 812, 820; AIMD 90/385/EEC; ISO 13485; MEDDEV 2.12-1; ISO 14971. 

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