Jobs
>
Irvine

    Regulatory Affairs Specialist - Irvine, United States - Brett Fisher Group

    Brett Fisher Group
    Brett Fisher Group Irvine, United States

    1 day ago

    Default job background
    Description

    Job Description

    Job Description

    This is a rare opportunity to join the global regulatory team of an innovative, fast-paced, medical device company. The Company values intellectual curiosity, self-starters with a willingness to grow and expand their impact on the organization, employees who find meaning in working with medical devices that improve patient outcomes, and a steadfast commitment to doing the right thing.

    The role of the Regulatory Affairs Specialist will be to support the global regulatory affairs of the business with a specialized focus on the United States.

    This position will be primarily responsible for obtaining and maintaining all necessary United States federal and state regulatory approvals for company products, providing strategic direction, oversight, and alignment with company processes, and ensuring company-wide compliance with all applicable United States federal and state regulatory requirements. This position will report to the Regulatory/Quality Director, based in the UK HQ.

    Main Tasks/Accountabilities

    • Lead regulatory strategy and submissions to the FDA and state regulatory authorities for new product approvals and supporting activities for existing ones.
    • Provide regulatory guidance to the assigned product development team to ensure the documents the team develops will meet the needs of the regulatory submissions.
    • Review technical documentation, i.e. test reports, test protocols, etc., for completeness and compliance with regulatory standards. Review includes using scientific judgment to guide the teams in understanding how to close any gaps that exist.
    • Timely compile materials for license renewals (including states), updates, and registrations.
    • Review company marketing literature for compliance with applicable regulations.
    • Maintain a thorough knowledge of current QSR and ISO requirements as they apply.
    • May support some Quality Management Functions, as needed.

    Qualifications & Skills:

    • B.S. Degree in a Science or Engineering or equivalent business experience.
    • At least 3 years experience working in the regulatory affairs department of a medical device company.
    • Knowledge of global Class I, II and/or III medical device requirements is preferred.
    • Demonstrated project management skills to plan, conduct, and implement system assessments.
    • Experience and demonstrated success communicating with state and federal regulatory agencies.
    • Prior experience handling FDA and Notified Body inspections is highly preferred.
    • Professional certification(s) (e.g., RAPS, CQA, CQM and/or CQE) are desired but not required.
    • Experience working with 510k submissions is desired but not required.
    • Ability to interpret domestic and international regulations as they apply to company activities.
    • Legally authorized to work in the United States.
    • Licensed in California as Designated Representative in Charge for Wholesaler ("DRIC") preferred; qualifications to obtain DRIC license required. Qualifications can be found here:

    Work Conditions: This role is an in-office position at The Company's U.S. headquarters in Irvine, CA. Travel may be required to assist with inspections or meet with regulatory authorities as needed.



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

    The Regulatory Affairs Specialist III, 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 provides direct Worldwide Regulatory ...


  • 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 ...


  • Intellectt Inc Irvine, United States

    Role: Regulatory Affairs Specialist · Location: Irvine, CA · Job Type: Contract · The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system. The position requires that they d ...


  • 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 ...


  • University Of California Irvine Irvine, United States

    · Job Opening ID: 69779 Reports To: Director of Graduate Studies Working Title: GRADUATE AFFAIRS SPECIALIST Department: SOM-Graduate Studies Bargaining Unit: 99 FLSA: Exempt Payroll Job Code: Job Location: UCI Campus- Irvine Percent of Time: 100% Work Schedule: 8-5, M-F Employee ...


  • 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 ...


  • 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 ...


  • Trinus Irvine, United States

    Job Description · Job DescriptionJob 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 pro ...


  • Trinus Irvine, United States

    Job Description · Job DescriptionJob 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 p ...


  • ClinChoice Irvine, United States

    Position: Senior Regulatory Affairs Specialist · Employment type: 1 year Contract/ Permanent · Location: Jacksonville, FL or Irvine CA (ONSITE 2 days per week - HYBRID ROLE) · ClinChoice is a global CRO that offers high-quality one-stop service to biopharmaceutical, medical devic ...


  • Intellectt Inc Irvine, United States

    Hello Everyone, · Greetings of the day. · This is Vydehi from Intellectt Inc. We currently have an opening for a Sr Regulatory Affairs Spec with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated r ...


  • Intellectt Inc 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 finalizatio ...


  • NeuroVasc Technologies, Inc. Irvine, United States

    We are NeuroVasc Technologies We deliver excellence through innovation with integrity. · Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execut ...


  • Intellectt Inc Irvine, United States

    : Sr Regulatory Affairs Spec · : Irvine, CA · Duration: 09 Months · Must be able to speak Japanese · Job Description: · Summary: · The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. · Key Resp ...


  • 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 ...


  • Entegee Irvine, United States

    Job Description · Job DescriptionJob 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: · Bachelor's degre ...


  • Jobot Irvine, United States

    Looking for an amazing Regulatory Affairs Specialist to join a growing startup medical device company · This Jobot Job is hosted by: Aaron Erickson · Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. · Salary: $80,000 - $120,000 per y ...


  • OrthAlign Irvine, United States

    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 sufficient t ...


  • OrthAlign Inc. Irvine, United States

    Job Description · Job DescriptionSalary: $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, orga ...


  • 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 organization's products. Work with RA Leadership and other members of the RA team ...