Tandym Group
Sr. RA Specialist
Tandym Group, Irvine, California, United States, 92713
A recognized services company in California is currently seeking an experienced Regulatory Affairs Specialist to join their staff in the Greater Los Angeles area in a Senior-level position.
Responsibilities:
The Senior Regulatory Affairs Specialist will:Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodiesMaintain company registrations and device listings in the US, Canada, and the EUAnalyze and reports department metricsPerform and support internal, external, and third-party audits.Evaluate compliance with applicable regulations, project policies, and proceduresReview and write standard operating procedures (SOPs) and other RA/QA policies, as necessaryCompose audit plans and reportsConduct audits and inspections of GMP and non-regulated documentationTrack internal and external corrective and preventive actionsPerform other duties, as neededQualifications:
5+ years of experience in Regulatory AffairsKnowledge and understanding of related State and Federal regulations and proceduresKnowledge of FDA 510K and ISO 13485 StandardsKnowledge of Regulatory Affairs regulations, guidance, and proceduresMicrosoft Office proficientSolid analytical, quantitative and problem solving skillsGreat interpersonal skillsExcellent communication skills (written and verbal)Strong attention to detailHighly organizedDesired Skills:
Bachelor's DegreeCertification in Regulatory Affairs and Auditing
Responsibilities:
The Senior Regulatory Affairs Specialist will:Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodiesMaintain company registrations and device listings in the US, Canada, and the EUAnalyze and reports department metricsPerform and support internal, external, and third-party audits.Evaluate compliance with applicable regulations, project policies, and proceduresReview and write standard operating procedures (SOPs) and other RA/QA policies, as necessaryCompose audit plans and reportsConduct audits and inspections of GMP and non-regulated documentationTrack internal and external corrective and preventive actionsPerform other duties, as neededQualifications:
5+ years of experience in Regulatory AffairsKnowledge and understanding of related State and Federal regulations and proceduresKnowledge of FDA 510K and ISO 13485 StandardsKnowledge of Regulatory Affairs regulations, guidance, and proceduresMicrosoft Office proficientSolid analytical, quantitative and problem solving skillsGreat interpersonal skillsExcellent communication skills (written and verbal)Strong attention to detailHighly organizedDesired Skills:
Bachelor's DegreeCertification in Regulatory Affairs and Auditing