Be an early applicantLess than 25 applicants

Company

Canon Medical Systems USA, Inc. · 5 hours ago

Mgr Regulatory Affairs

United States

Full-time

Remote

Mid, Senior Level

$130K/yr - $130K/yr

5+ years exp

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Responsibilities

Participate in the planning of meetings between the FDA and CMSU regarding regulatory issues as assigned by the Director, Regulatory Affairs.

Provide guidance to CMSC Business Unit Managers and Engineering Managers in pre-market submission preparation.

Support activities related to FDA compliance activities including GMP inspections, recalls and MDR's as assigned by the Director, Regulatory Affairs.

Support legal actions as required by the legal department or directed by the Director, Regulatory Affairs.

Support training/development of RA staff.

Provide training to CMSU and CMSC employees on regulatory items.

Audit CMSU's policies and procedures, as required.

Submit and track pending FDA submissions (510K's, PMAs), IDE, and IRB, as applicable.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

FDA complianceRegulatory AffairsDirect FDA experienceGMP inspectionsPre-market submissionSubmission trackingTraining developmentPolicy auditingLegal supportFDA laws

Required

Participate in the planning of meetings between the FDA and CMSU regarding regulatory issues as assigned by the Director, Regulatory Affairs.

Provide guidance to CMSC Business Unit Managers and Engineering Managers in pre-market submission preparation.

Support activities related to FDA compliance activities including GMP inspections, recalls and MDR's as assigned by the Director, Regulatory Affairs.

Support legal actions as required by the legal department or directed by the Director, Regulatory Affairs.

Support training/development of RA staff.

Provide training to CMSU and CMSC employees on regulatory items.

Audit CMSU's policies and procedures, as required.

Submit and track pending FDA submissions (510K's, PMAs), IDE, and IRB, as applicable.

Current knowledge of all laws pertaining to FDA clearance.

4 Year/Bachelor’s Degree in regulatory, engineering, or physical sciences.

5 years Direct FDA experience.

Will work PST hours.

Preferred

Prefer candidate to reside on the West Coast.

Company

Canon Medical Systems USA, Inc.

Mission Canon Medical Systems USA delivers innovative imaging solutions and services through our Made for Life philosophy to improve the quality of life for all people.

Founded in 1977

Tustin, California, USA

1001-5000 employees