Affairs specialist jobs in Irvine, CA

 ...Minimum of three (3) years of Medical device industry experience. Desired Qualifications # Minimum one (1) year Regulatory Affairs Experience. # Leadership skills. # Ability to work well in a team environment. # Detail oriented. # Proven analytical abilities... 

 ...we go above and beyond to make an impact in the lives of our patients and customers. We are currently hiring a Regulatory Affairs Specialist for our sunny Lake Forest, California site. We are looking for dynamic, inspiring, inclusive team members who collaborate with... 

 ...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... 

Job Description: Pay Range $44.60hr - $49.60hr Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines ...

 ...Advantage Technical is seeking a Regulatory Affairs Specialist for our client in Irvine, CA. This position is Hybrid - Monday - Wednesday - Friday on-site and Tuesday - Thursday remote. Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities... 

 ...integrity. Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product...  ...; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development... 

 ...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 organizations products. Work with RA Leadership and other members of the... 

Position SummaryThe primary responsibility of the Senior Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The Sr. RAS is also responsible for ensuring products and procedures comply with regulatory... 

Overview: Represents the Regulatory Affairs function in project teams, and manages regulatory projects to established timelines and...  ...oversee completion of prioritized tasks to Regulatory Affairs specialists as appropriate. Review and approve document change orders (... 

 ...Description: 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... 

Job TitlePrincipal Regulatory Affairs SpecialistJob DescriptionPrincipal 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 is a clinical... 

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 preparation revision of technical files when needed, update labeling to comply with IVDR requirements...

 ...supportive team environment is a key requirement for this role. ?? Position Description: As an Associate Specialist in Post-market Regulatory Affairs, plays a crucial role in ensuring that our medical devices continue to meet regulatory requirements and maintain... 

 ...continue to develop strong working relationships with internal and external customers. Responsibilities: The Regulatory Affairs Specialist (RAS) is responsible for the management of global and regional regulatory projects, including, but not limited to, the... 

 ...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... 

 ...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 of documentation... 

 ...0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry Working knowledge of FDA, and CE marking requirements for IVD products is a plus Able to work independently and with others... 

 ...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:... 

 ...Job Description Job Description Summary: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Key Responsibilities: Create regulatory submissions (exercising judgment to... 

Job Description Job Description Description: RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery...