Regulatory affairs jobs in Irvine, CA

 ...Regulatory Affairs Specialist Career Opportunity Job Title Regulatory Affairs Specialist FLSA Salaried Exempt Department Regulatory Reports To Director of Regulatory Affairs/ Chief Operating Officer Download the job description To apply, e-mail your resume to This email... 

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... 

 ...registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device listings...  ...preferred. Minimum five (5) years of experience in Regulatory Affairs. Knowledge and Abilities: Proficient knowledge of... 

 ...Position Overview: Join Applied Medical and play a crucial role in revolutionizing medical devices. As a Specialist in Premarket Regulatory Affairs, you will play a pivotal role in ensuring compliance with regulatory requirements during the early stages of product... 

 ...Description The Sr. Regulatory Affairs Specialist works under minimal supervision supporting cross- functional teams with regulatory strategy and execution for new devices and device modifications. Responsibilities Participate as the regulatory representative... 

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... 

 ...touch. For more information, visit Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance... 

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 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... 

 ...Job Title Sr. Regulatory Affairs Specialist-CT/AMI Job Description The Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving... 

 ...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... 

 ...please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory... 

 ...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: 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... 

 ...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... 

 ...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 The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization's products. Work with... 

 ...Job Description Job Description Job Posting Summary: Seeking a Regulatory Affairs Specialist to manage updates and compliance for technical files and labeling under the new IVDR requirements, ensuring seamless transition from IVD Directive. Job Requirements:... 

 ...$100k + DOE OrthAlign, Inc. , a 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... 

 ...Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99. How you will make an impact: As a Manager, Regulatory Affairs, you are responsible for completing and maintaining regulatory approvals and clearances of assigned products. Representing...