Jobs
>
Irvine

    Regulatory Affairs Consultant - Irvine, United States - Redbock - an NES Fircroft company

    Default job background
    Description
    Regulatory Affairs Consultant
    Irvine, CA
    A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a

    Regulatory Affairs Consultant

    to support them for

    approximately 3 months . The consultant will need to work

    onsite at least 3 days/week .

    The Regulatory Affairs Consultant will be focused on the hands-on development of a

    Special 510k

    regulatory submission with a deadline of early July 2024.

    The Regulatory team is currently only 3 people so this consultant will need to work mostly independently to create the 510k submission.

    This consultant may also be involved in the review of test protocols in coordination with the R&D and Quality teams.

    Top Requirements

    :

    BS degree minimum
    5+ years of Medical Device industry experience as a Regulatory Affairs specialist
    Orthopedics device experience is a plus
    Experience with devices that have software components is a plus
    Able to independently develop a 510k submission, requires strong knowledge of all components/sections that go into this submission
    Experience with Special or Abbreviated 510k submissions
    Strong communication skills, able to collaborate effectively with cross-functional teams

    #J-18808-Ljbffr


  • Redbock - an NES Fircroft company Irvine, United States

    Regulatory Affairs Consultant · Irvine, CA · A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week. · The Regu ...


  • Redbock - an NES Fircroft company Irvine, United States

    A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a · Regulatory Affairs Consultant · to support them for · approximately 3 months . The consultant will need to work · onsite at least 3 days/week . · The Regulatory Affairs Consultant will ...


  • UnitedHealth Group Irvine, United States

    Maintain knowledge of current and impending regulations and legislation Triage and lead cross-functional teams for the implementation of complex new or existing regulatory issues, monitor, and communicate status Participate in the development of stra Regulatory Affairs, Regulator ...

  • UC Irvine Campus

    Avc, Strategy

    1 week ago


    UC Irvine Campus Irvine, United States

    Updated: Apr 19, 2024 · Location: Irvine-Campus · **Job Type**: · Department: VC Health Affairs Admin · **Job Opening ID**:67979 · **Reports To**: Chief of Staff, Health Affairs · **Working Title**: AVC, Strategy & Administration · **Department**: VC Health Affairs Admin · **Barg ...


  • Edwards Lifesciences Irvine, United States

    Job Description · For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every pat ...


  • Edwards Lifesciences Irvine, United States

    Job Description · Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll ...


  • Concordia University - Irvine Ca Irvine, United States

    **SUMMARY**: · The WINGS & First Gen Coordinator will play a key role in preparing the new incoming class of undergraduate students as they transition into college. This position will be responsible for faculty and staff to develop programming to prepare students for the academic ...


  • Edwards Lifesciences Irvine, United States

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...


  • Rancho Santiago Community College District Santa Ana, United States

    **Student Services Coordinator, Digital Dons** · **Rancho Santiago Community College District** · **Salary Range**: Grade 15: $72, $92,770.14/year · **Job Type**: Full Time · **Job Number**: CL · **Location**: Santa Ana, CA · **Division**: SAC Student Affairs · **Closing**: 6/13 ...


  • Charitable Ventures Orange County, CA, United States

    TITLE Production Assistant · FLSA STATUS Non-Exempt · PAY CLASS Part-Time · REPORTS TO OC World Founder / CV Human Resources · LOCATION Remote · **Who is Charitable Ventures?** · Founded in 2007, Charitable Ventures is a 501(c)3 nonprofit organization that provides incubation, so ...


  • Liebenzell Mission of USA Long Valley, United States

    **Liebenzell Mission of the USA** · **Is hiring a** · **Director of Business Administration** · (June 2022) · Liebenzell Mission began in 1899 as the German branch of Hudson Taylor's China Inland Mission. Settled in the Black Forest region of Germany, missionaries were sent to in ...


  • US Commander, Navy Installations Seal Beach, United States

    **Duties**: · Incumbent serves as a non-clinical consultant and facilitator on a wide variety of work and family life issues and concerns. Provides informative and tangible advice, assistance, and instruction to address customer concerns, needs and requirements associated with Na ...


  • Edwards Lifesciences Corp Irvine, United States

    For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every patient who should be ...


  • TalentBurst, Inc. Irvine, United States

    Title: Associate Analyst, Medical Affairs| Job ID: 6869-1 · Duration: 6 months · Location: Irvine, CA fully onsite) · Job Description: This is a unique opportunity to play an important role in the growing Transcatheter Mitral & Tricuspid Therapies (TMTT) Medical Affairs team, pr ...


  • Edwards Lifesciences Irvine, United States

    For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every patient who _should_ ...


  • California State University Pomona, United States

    **Job no**: 538130 · **Work type**: Staff · **Location**: Pomona · **Categories**: Unit 9 - CSUEU - Technical Support Services, Probationary, Full Time, Safety, On-site (work in-person at business location) · **Type of Appointment**: Full-Time, Probationary · **Collective Bargain ...


  • Intellectt Inc Irvine, United States

    Job Description: · This is a unique opportunity to play an important role in the growing Transcatheter Mitral & Tricuspid Therapies (TMTT) Medical Affairs team, providing innovative solutions to transform treatment for patients suffering from mitral and tricuspid heart disease. ...


  • Pyramid Consulting, Inc Irvine, United States

    Immediate need for a talented Specialist, Site Communications. This is a 06+ Months contract opportunity with long-term potential and is located in Irvine, CA (Onsite). Please review the job description below and contact me ASAP if you are interested. ​ · ​ · Job ID: · ​ · Pay R ...


  • Intellectt Inc Irvine, United States

    Title: Medical Affairs Analyst · Location: Irvine, CA (On-Site) · Duration: 6+ Months · Job Description: · This is a unique opportunity to play an important role in the growing Transcatheter Mitral & Tricuspid Therapies (TMTT) Medical Affairs team, providing innovative solution ...

  • Advance Nursing Services

    Lcsw/lmft

    2 weeks ago


    Advance Nursing Services Downey, United States

    **JOB TITLE**:Licensed Clinical Social Worker/Clinical Supervisor/LMFT · **SALARY**: between $90k - $90k/annum · **JOB DESCRIPTION**: · Advance Nursing Services recruits on behalf of Holliday's Helping Hands which is an organization that cares for homeless families and individual ...