Jobs
>
Irvine

    Regulatory Affairs Specialist - Irvine, United States - INTELLECTT INC

    Intellectt Inc background
    Description
    • Coursework, seminars, and/or other formal government and/or trade association training required
    • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
    • Good written and verbal communication skills and interpersonal relationship skills
    • Good problem-solving, organizational, analytical and critical thinking skills
    • Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
    • Solid knowledge and understanding of global regulatory requirements for new products or product changes.
    • Solid knowledge of new product development systems
    • Strict attention to detail
    • Ability to interact professionally with all organizational levels
    • Ability to manage competing priorities in a fast paced environment
    • Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
    • Ability to build productive internal/external working relationships
    • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control


  • Jenavalve Technology Inc Irvine, United States

    **Job Title**: Specialist, Clinical Affairs · **Supervisor/Manager Title**:Senior** **Manager, Clinical Affairs · **Job Description Summary**:Supports Clinical Research Associates (CRAs) to manage specific activities related to clinical projects. · **Responsibilities**: · - Provi ...


  • Orange County Sanitation District Fountain Valley, United States

    **Description**: · - What do **you **value in your next job? · At the **Orange County Sanitation District **our **Core Values **form the framework of our organization and reinforce our professional work ethic. If the following values ring true with you, we'd love to invite you to ...


  • Kelly Science, Engineering, Technology & Telecom Irvine, United States

    Regulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional S ...


  • Tucker Parker Smith Group (TPS Group) Irvine, United States

    Job Title: Regulatory Affairs Specialist · Location: Irvine, CA · Schedule: Hybrid, Monday to Friday, 8 AM to 5 PM, with on-site work Tue/Thur · Duration: 1 year with potential to extend/ convert to internal FTE · no fully remote option · hourly rate of $40-45/hr · About Us: We a ...


  • Kelly Science, Engineering, Technology & Telecom Irvine, United States

    Regulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional ...


  • Kelly Science Engineering Technology & Telecom Irvine, United States

    Regulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional ...


  • Edwards Lifesciences Irvine, United States

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorit ...


  • Compunnel Irvine, United States

    Job Description: 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 protect proprietary information) for final ...


  • Ledgent Technology Irvine, United States

    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 protect proprietary information) for finalization ...


  • MyKelly Irvine, United States Full time

    Regulatory Affairs Specialist · The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U.S. and international regulatory requirements. The Regulatory Affairs Specialist provid ...


  • Motion Recruitment Irvine, United States

    Our client is seeking a motivated Regulatory Affairs Specialist. · The details are mentioned below: · Key Responsibilities: · • Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track time ...


  • Nihon Kohden Irvine, United States

    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 RA team t ...


  • Trinus Irvine, United States

    Job Description · Job DescriptionSummary: · 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 protect proprieta ...


  • Cypress HCM Irvine, United States

    · 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 · Able to wo ...


  • INTELLECTT INC Irvine, United States

    Coursework, seminars, and/or other formal government and/or trade association training required · Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel · Good written and verbal communication skills and interpersonal relationship skills · Good problem ...


  • Nelson Connects Irvine, United States

    Location: Irvine, CA · Shift: 8am-5pm (hybrid) · Type: 12 month 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 ...


  • Infosoft, Inc. Irvine, United States

    Job Title: Senior Regulatory Affairs Specialist · Duration: 9 months · Location: Irvine, CA (Onsite) · Shift: 8 am to 5 pm. · Our Client is a Global medical device Manufacturer. · We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory a ...


  • Inari Medical Irvine, United States

    · 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 supporting cross-functiona ...


  • Endologix Irvine, United States

    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 obj ...


  • Infosoft, Inc. Irvine, United States

    Job Title: · Senior Regulatory Affairs Specialist · Duration: · 9 months · Location: · Irvine, CA (Onsite) · Shift: 8 am to 5 pm. · Our Client is a · Global medical device Manufacturer. · We are looking for a · Senior Regulatory Affairs Specialist · to complete and maintain ...