Regulatory affairs assistant jobs in Irvine, CA

 ...Regulatory Affairs Specialist Career Opportunity Job Title Regulatory Affairs Specialist FLSA Salaried Exempt Department Regulatory Reports...  ...for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance... 

 ...revolutionizing medical devices. As a Specialist in Premarket Regulatory Affairs, you will play a pivotal role in ensuring compliance with...  ...support regulatory documentation requests and provide submittal assistance. Exhibit a strong technical understanding of the product... 

 ...submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company...  ...five (5) years of experience in Regulatory Affairs. Knowledge and Abilities: Proficient...  ...and need a reasonable accommodation to assist with your job search or application for... 

Overview: Represents the Regulatory Affairs function in project teams, and manages regulatory projects to established timelines and budgets. Oversees and ensures compliance with state, federal and International medical device regulations and overall regulatory departmental... 

 ...Description The Sr. Regulatory Affairs Specialist works under minimal supervision supporting cross- functional teams with regulatory strategy...  ...as needed. Develop and maintain regulatory procedures. Assist in keeping the company informed of current and proposed... 

 ...LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory affairs for device development projects...  ...activities are in line with global business priorities. + Assists in training and mentoring of personnel and performs peer... 

Overview: The Director, Regulatory Affairs for EMEA is responsible for successful completion of complex regulatory projects, including pre-submissions and IDE submissions to FDA, IRB submissions, Ethics Committee submissions, EU Annex XIV submissions and as well as... 

Support the EU's In Vitro Diagnosic Regulation (IVDR) transition activities that will impact all Bio-Rad products currenlty CE Marked under the IVD Directive. Activites include preparationrevision of technical files when needed, update labeling to comply with IVDR requirements...

 ...Job Title Sr. Regulatory Affairs Specialist-CT/AMI Job Description The Senior RA Specialist will play a critical role in ensuring...  ...Regulatory Affairs representative for the CT/AMI Systems and assists with regulatory issues related to such items as labeling and... 

 ...Job Title Principal Regulatory Affairs Specialist Job Description Principal Regulatory Affairs Specialist (U.S. Hub based) Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product... 

 ...Instagram, YouTube and LinkedIn. Job Description The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with...  ...and information requirements with limited supervision. * Assists with preparation of submissions, supplements, and... 

 ...Reports, Design Dossier, Technical Files, Australian Technical Files, Canadian Licenses, and Japan submissions. Essential Requirements Checklists, Design Dossiers, Technical Files and De Regulatory, Remote, Neuro, Principal, Specialist, Technical, Manufacturing, Education... 

 ...The primary responsibility of the position is to support regulatory strategy and registration across global markets for a defined...  ...external customers. Responsibilities: The Regulatory Affairs Specialist (RAS) is responsible for the management of global and... 

 ...Job Opening ID: 67661 Reports To: UCI Temporary Employment Services (TES) Manager Working Title: Temporary Assistant Regulatory Affairs Coordinator Department: UCI Temporary Employment Services (TES) Department Bargaining Unit: RX FLSA:... 

 ...Job Description Job Description The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy...  ...transfers, layoffs, company-sponsored training, education, tuition assistance, and social and recreational programs) in accordance with... 

 ...Job Opening ID: 67886 Reports To: Director of Clinical Research Operations Working Title: SENIOR REGULATORY AFFAIRS COORDINATOR Department: UCI Ctr for Clinical Research Bargaining Unit: RX FLSA: Exempt Payroll Job Code: 007888 Job Location: UCI Campus... 

 ...assignment (Temporary) Industry: Life Science Pay Range: $40-$45/hr Nelson Connects is presently seeking an experienced Regulatory Affairs professional with experience In Virto Diagnostics (IVDs) in Irvine, ,CA. In this role you will be providing regulatory... 

 ...Job Description Job Description Regulatory Affa irs Specialist This is an exciting opportunity to join an industry leading biotech company leading. The Regulatory Affairs Specialist will be responsible for supporting In Vitro Diagnostic Regulation (IVDR) transition... 

 ...Job Opening ID: 65652 Reports To: Director of Student Affairs Working Title: Student Affairs Assistant Department: ICS/Student Affairs/UG Bargaining Unit: CX FLSA: Non-Exempt Payroll Job Code: 004722 Job Location: UCI Campus- Irvine Percent of Time... 

 ...Smart Technology, growing medical device company, has an immediate opening for a Senior Regulatory Affairs Specialist responsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to...