A Regulatory Affairs Specaislist job in San Diego, CA needs to be filled immediately by Adecco Medical & Science. In this job you'll be responsible for maintaining and ensuring that the company quality system meets FDA requirements for class I medical devices (IVD and ASR) and International In-vitro Diagnostic Medical Devices Directives. You will also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international). Adecco Medical & Science is a division of the world leader in medical and scientific professional recruiting.
Manage and establish / maintain compliance with FDA QSRs (GMP) (including company registration, new product submissions, establishing FDA communication/channels for compliance on medical device listings/classifications.
Establish / maintain compliance with the EU IVD directive and other international regulations and standards as required, including registrations
Maintain Technical Documentation files in compliance with international requirements
Ensure compliance of labeling and advertising for all products in a regulated class.
Support the QMS and regulatory requirements, and act as a resource to ensure quality and regulatory compliance
Monitor and trend key Regulatory objectives and present data to Senior management during management review meetings
Support timely document search and delivery during external regulatory audits.
Travel up to 10% may be required.
Bachelors of Science Degree
3+ years' experience in Regulatory Affairs for Medical Devices and/or IVD
International Product registrations success worldwide
Experience with the maintenance of technical files and Vigilance Reporting
Experience with writing standard operating procedures and work instructions
Experience with developing and mplementing Regulatory Management Control Systems
Experience with Canadian, ISO 13485, and all international market medical device requirements is a plus
Excellent communication skills (verbal and written) and good interpersonal skills with customer-oriented focus
Strong ability to handle multiple priorities simultaneously
Meticulous attention to detail and accuracy
Ability to work in a team environment, fast learner with ability to clarify areas of ambiguity
Good working knowledge of the Microsoft Office software
If you are interested in this then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com or email your resume to Melody.Lam@adeccona.com.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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