Regulatory Affairs Specialist (Orange County, CA)

SNAPSHOT!

Looking for the next step in your career as a Regulatory Affairs Specialist that will be reporting directly to the VP of quality and Regulatory Affairs! READ ON!!

Our client is a privately held medical device company located in Orange County, California, and is developing innovative cryoablation technologies that create continuous, transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, atrial flutter, and ventricular tachycardia.

Immediate need for a Regulatory Affairs Specialist, Orange County CA who possess:

• Bachelor’s degree (B.S.) from four-year College or University one-two (1-2) years minimum experience in regulatory affairs.

• Knowledge and understanding of Quality and Regulatory concepts and applicationStrong analytical, planning and organizational skillsStrong interpersonal and communications skills (oral & written)Self-starter with ability to work independently under pressure and react quickly to changing prioritiesProficient in MS Office products

• Current knowledge of FDA Guidelines, Medical Device Directives (93/42/EC), ISO 13485, and standards applicable to company products.

Key responsibilities include:

• Support and prepare documentation for regulatory submissions and registrations (FDA and EU regulatory entities)IDE, PMA, 510(k), Design Dossiers, Technical Files.

• Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files.

• Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.

• Support communication with FDA and Notified Body representative while preparing responses to deficiency letters and/or questions from regulatory agencies.

• Represent Regulatory Affairs on Engineering & R&D product development project teams to ensure all regulatory requirements are met throughout the development process.

• This position will report directly to the VP, Quality and Regulatory Affairs.

For immediate considerations please email your resume to admin@snapstaffing.com