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Regulatory Approval Specialist Jobs

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  • 3.5
    PacificSource Health Plans – Bend, OR
    6 days ago 6d
    departments and teams. Attending weekly meetings; review and approve external communications; and monitor operational performance…
  • 3.7
    Biomérieux – Saint Louis, MO
    Est. Salary $52k-$75k
    7 days ago 7d
    opportunities. POSITION DESCRIPTION The regulatory affairs specialist contributes to the "innovate and develop" process… implementation of regulatory procedures. Manages communication with regulatory agencies and notified body on regulatory procedures.…
  • 3.9
    MSD – West Point, PA
    Est. Salary $65k-$95k
    5 days ago 5d
    Sr. Specialist, Regulatory Affairs, CMC (Pre-approval) Job Sr. Specialist, Regulatory Affairs, CMC (Pre-approval)-REG****… product lifecycle from IND to post-approval changes. Identify and communicate potential regulatory issues to GRACS CMC management…
  • 3.6
    Merck – West Point, PA
    Est. Salary $68k-$96k
    5 days ago 5d
    West Point, PA, US Company: MSD Sr. Specialist, Regulatory Affairs, CMC (Pre-approval)-REG****** Description Merck… Associate Director or Director, the Senior Specialist is responsible for implementing CMC regulatory strategies for assigned pharmaceutical…
  • 3.8
    AtriCure – Minneapolis, MN
    Est. Salary $75k-$105k
    NEW
    AtriCure. Position Summary: The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain… extension and will provide regulatory supervision on post-market product changes to maintain marketing approvals. Roles and Responsibilities…
  • 3.7
    Florida Hospital – Orlando, FL
    Today 8hr
    second-level reviews. Maintains current knowledge of payer mix and regulatory requirements, updates the Interdisciplinary Clinical Team,… Florida Hospital Orlando seeks to hire a Utilization Review Specialist in the Center for Behavioral Health who will embrace our mission…
  • 4.5
    Advanced Clinical – Valencia, CA
    Est. Salary $62k-$89k
    5 days ago 5d
    Senior Regulatory Affairs Specialist in Valencia, California. The Senior Regulatory Affairs Specialist will apply regulatory expertise… management, to facilitate the review and approval of regulatory applications Represent Regulatory Affairs on assigned project teams…
  • 3.5
    Novozymes – Franklinton, NC
    6 days ago 6d
    world and the way people live and work. Regulatory Associate/RegulatorySpecialist As a world leader in biotechnology, Novozymes… is driven to change the world. As our Regulatory Associate/RegulatorySpecialist, you will help Novozymes in achieving our…
  • 3.1
    Chart Industries – Canton, GA
    Est. Salary $58k-$83k
    14 days ago 14d
    effort to secure the required product approvals including document submissions to regulatory authorities and notified bodies. Proactively… releases and changes to develop Regulatory Plans including required testing, approvals, labeling and post market reporting. Work…
  • 4.5
    Advanced Clinical – North Haven, CT
    Est. Salary $46k-$68k
    NEW
    professional to join a well-known client’s team as Regulatory Affairs Specialist in New Haven, Connecticut. Their work will have… notifications/registrations of changes that may impact the regulatoryapprovals Assist with preparation of U.S. FDA submissions, Design…
  • 3.6
    Medtronic – Fridley, MN
    Est. Salary $100k-$129k
    NEW
    with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new… The Prin Regulatory Affairs Specialist is responsible for developing pre- and post-market regulatory strategies, preparing…
  • 3.6
    Medtronic – Fridley, MN
    Est. Salary $60k-$80k
    NEW
    existing approved products. Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to… The Regulatory Affairs Specialist is responsible for developing pre- and post-market regulatory strategies, preparing U.S…
  • 3.9
    Boston Scientific – Valencia, CA
    Est. Salary $78k-$107k
    Today 6hr
    Primary Function: Support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations… Participate in activities to ensure compliance with worldwide regulatory requirements. Duties: Prepare submissions(i.e. PMA…
  • Randstad Life Sciences – Waltham, MA
    27 days ago 27d
    Job Title: Regulatory Affairs Specialist II Position Description The PRE Team are the experts on the regulatory requirements… within PSRs across applicable regulatory submission documents (RMP, DSUR, RSI) to support final approval and signature by the GSO/QPPV…
  • 3.3
    Aerotek – Schaumburg, IL
    NEW
    industry has an exciting opportunity available for a Regulatory Affairs Specialist. Responsibilities: Knowledge of North American… products requiring governmental approval. Assist in developing procedures to ensure regulatory compliance. Communicate with sales…
  • 3.8
    AtriCure – Minneapolis, MN
    Est. Salary $75k-$105k
    8 days ago 8d
    Senior International RegulatorySpecialist is responsible for: Prepare written global regulatory strategies for new… marketing approvals Participate as core team member on development teams, providing RA guidance, and project regulatory assessments…
  • 3.6
    Medtronic – Santa Rosa, CA
    Est. Salary $90k-$118k
    NEW
    Position Description The Senior Regulatory Affairs Specialist will provide regulatory affairs support for Class II and Class… products. The Senior Regulatory Affairs Specialist is responsible for developing pre- and post-market regulatory strategy, preparing…
  • 3.6
    Karl Storz Endoskope – Charlton, MA
    NEW
    input to Marketing on the approval of marketing literature to ensure compliance with FDA cleared or approved claims and other applicable… Devices Regulations. Job Function: Perform regulatory submission assessment for changes/modifications made to a…
  • 3.9
    Ghirardelli Chocolate – San Leandro, CA
    Est. Salary $49k-$80k
    NEW
    innovation. As a Regulatory Compliance Specialist, you will be responsible for developing, reviewing, and approving food and nutrition… as providing regulatory technical support to R&D. As a RegulatorySpecialist you will become an expert in regulatory matters by…
  • 3.5
    Molson Coors Brewing Company – Milwaukee, WI
    Est. Salary $48k-$68k
    Today 2hr
    legal, government or insurance environment with experience in regulatory compliance. Paralegal certificate Ability to interpret… maintained. § Notification to brewery controllers of approved federal and state licensing. Completion and timely filing…
  • 3.7
    Alvogen – Norwich, NY
    NEW
    satisfy regulatory requirements and communicate with internal and external customers. Coordinate document edit/approval processes… Services (MDAS) Documentation Specialist performs activities related to authoring, approval, storing, and archiving company…
  • 5.0
    KSE Partners – Charlton, MA
    NEW
    input to Marketing on the approval of marketing literature to ensure compliance with FDA cleared or approved claims and other applicable… Devices Regulations. Job Function: Perform regulatory submission assessment for changes/modifications made to a…
  • 3.6
    Agilent Technologies – Santa Clara, CA
    Est. Salary $103k-$143k
    20 days ago 20d
    Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals of Companion Diagnostic… are met. • Provide regulatory assessments and plans for international product registrations and approvals. • Interact and collaborate…
  • 3.1
    EMMES Corporation – Rockville, MD
    1 days ago 17hr
    research. Emmes is seeking a Regulatory Document Specialist. The Regulatory Document Specialist is responsible for the overall… May supervise and/or mentor less experienced Regulatory Document Specialist personnel Participates on department teams or…
  • 3.6
    Philips – Bothell, WA
    Est. Salary $71k-$105k
    1 days ago 16hr
    product development teams, the RegulatorySpecialist will provide timely and valued regulatory guidance (written and / or verbal… Provide significant regulatory support to ongoing PMA activities. Additionally, the RegulatorySpecialist will: Communicate…
  • 3.0
    Kinetic Concepts – North Richland Hills, TX
    Est. Salary $45k-$70k
    1 days ago 18hr
    Job Description The RegulatorySpecialist will prepare regulatory filings to allow for KCI products to be marketed globally… establish global regulatory strategies and plans needed to obtain the appropriate regulatory clearances/approvals for new and existing…
  • 3.3
    Randstad US – Waltham, MA
    27 days ago 27d
    Job Title: Regulatory Affairs Specialist II Position Description The PRE Team are the experts on the regulatory requirements… within PSRs across applicable regulatory submission documents (RMP, DSUR, RSI) to support final approval and signature by the GSO/QPPV…
  • Joule – Summit, NJ
    1 days ago 24hr
    is seeking a Biologic's Specialist for a contract position. Responsibilities: -Assist the Regulatory-CMC Biologics team with… projects to support department goals and objectives. -Support Regulatory CMC Biologics group in the preparation of submissions including…
  • 3.5
    Cook Group – Vandergrift, PA
    Est. Salary $42k-$66k
    12 days ago 12d
    The Regulatory Affairs / Regulatory Reporting Specialist at Cook Vandergrift is responsible for the planning and preparation of… of submissions to obtain regulatoryapprovals for new and modified Class I, II, III and IV medical devices in specific markets…
  • 3.9
    UNC Health Care – Raleigh, NC
    6 days ago 6d
    applicable regulatory requirements. 1.11 Verify compliance with regulatory requirements. Verify date of IRB approval before… Maintain complete regulatory files for each protocol. 1.3 Submit protocol to central IRB for approval following IRB policies…
  • 1.0
    Ultimate Nutrition – West Palm Beach, FL
    1 days ago 23hr
    nutrition and regulatory technical information for ingredients and products Review and approve label graphics for regulatory compliance… Nutrition & RegulatorySpecialist Company Description Ultimate Nutrition, Research and Development Division is a market-leading…
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