Jobs
>
Des Plaines

    Regulatory Affairs Specialist - Des Plaines, United States - ProKatchers LLC

    ProKatchers LLC
    ProKatchers LLC Des Plaines, United States

    2 weeks ago

    Default job background
    Description

    Job Title: Regulatory Affairs Specialist

    Location: Des Plaines, Illinois, United States

    Duration: 08 Months

    Job Description:

    Description:

    • Must have 1-2 years of experiences in Medical Device Reg Affairs
    • Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessments Have working knowledge in US and EU medical device submissions Work cross-functionally and in a matrixed environment Have experience with continuous improvement activities.
    • Duties:. Assist the strategy implementation and operations for regulatory affairs activities, including preparing documents and deliverables to supporting change notifications and submission activities , license renewals etc.
    • Working knowledge of the regulations including EU MDR would be helpful in understanding the regulatory requirements for IVDR implementation.
    • Identify opportunity for regulatory affair processes and drive changes to completion. This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
    • Additionally Provide tracking, reporting, and presentation to management for the project activities.
    • Regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics.
    • Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
    • Duties: Responsible for implementing and maintaining the effectiveness of the quality system.
    • Supports manufacturing/operations day to day activities for change control.
    • Provides consultation/advice to regulatory specialist for change control and product development.
    • Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.
    • Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation, labeling, field support.
    • Applies regulatory and technical knowledge to a wide variety of complex work assignments.
    • Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
  • McCain Foods USA, Inc.

    Regulatory Affairs Specialist

    1 day ago

    McCain Foods USA, Inc. Oakbrook Terrace, United States

    **Position Title**:Regulatory Affairs Specialist · **Position Type**: Regular - Full-Time · **Position Location**:Oakbrook Terrace · **Requisition ID**: 28326 · The Regulatory Affairs Specialist is responsible for product composition and label regulatory compliance for finished g ...

  • ProKatchers

    Regulatory Affairs Specialist

    1 week ago

    ProKatchers Des Plaines, United States

    Job Title: Regulatory Affairs Specialist · Location: Des Plaines, Illinois, United States · Duration: 08 Months · Job Description: · Description: · Must have 1-2 years of experiences in Medical Device Reg Affairs · Have working knowledge in EU MDR Have working knowledge in ...

  • Medline Industries

    Regulatory Affairs Specialist

    1 week ago

    Medline Industries Winnetka, United States

    JOB SUMMARY: · Under general supervision, the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch market ...

  • McCain Foods

    Regulatory Affairs Specialist

    1 week ago

    McCain Foods Villa Park, United States

    ? ? Position Title: Regulatory Affairs Specialist Position Type: Regular - Full-Time ? Position Location: Oakbrook Terrace Requisition ID: 28326 ? The Regulatory Affairs Specialist is responsible for product composition and label regulatory complianc Regulatory Affairs, Specialis ...

  • McCain Foods

    Regulatory Affairs Specialist

    1 week ago

    McCain Foods Villa Park, United States

    Position Title: Regulatory Affairs Specialist · Position Type: Regular - Full-Time · Position Location: Oakbrook Terrace · Requisition ID: 28326 · The Regulatory Affairs Specialist is responsible for product composition and label regulatory compliance for finished goods manufactu ...

  • GForce Life Sciences

    Regulatory Affairs Specialist

    1 week ago

    GForce Life Sciences Lake Forest, United States

    The position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations. · TERM & START · 1-year contract starting 6/10/24 with possibil ...

  • GForce Life Sciences

    Regulatory Affairs Specialist

    2 days ago

    GForce Life Sciences Lake Forest, United States

    The position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations. · TERM & START · 1-year contract starting 6/10/24 with possibili ...

  • GForce Life Sciences

    Regulatory Affairs Specialist

    6 days ago

    GForce Life Sciences Lake Forest, United States

    Regulatory Affairs Specialist – Onsite in Lake Forest, IL · Must be able to work W2 · Summary · Our client, a Fortune-500 Medical Device Company, has requested that we find them a regulatory affairs specialist to provide support and ensure efficient and compliant business proces ...

  • GForce Life Sciences

    Regulatory Affairs Specialist

    1 week ago

    GForce Life Sciences Lake Forest, United States

    The position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations. · TERM & START · 1-year contract starting 6/10/24 with possibi ...

  • DivIHN Integration Inc

    Specialist Regulatory Affairs

    1 week ago

    DivIHN Integration Inc North Chicago, United States

    DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 200 ...

  • GForce Life Sciences

    Regulatory Affairs Specialist

    6 days ago

    GForce Life Sciences Lake Forest, United States

    Regulatory Affairs Specialist Onsite in Lake Forest, IL · Must be able to work W2 · Summary · Our client, a Fortune-500 Medical Device Company, has requested that we find them a regulatory affairs specialist to provide support and ensure efficient and compliant business proce ...

  • GForce Life Sciences

    Regulatory Affairs Specialist

    1 day ago

    GForce Life Sciences Lake Forest, United States

    The position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations. · TERM & START · 1-year contract starting 6/10/24 with possibi ...

  • DivIHN Integration

    Regulatory Affairs Specialist

    1 week ago

    DivIHN Integration Lake Bluff, United States

    DivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, ...

  • Northwestern Medicine

    Regulatory Affairs Specialist

    2 days ago

    Northwestern Medicine Chicago, United States

    Benefits · $10,000 Tuition Reimbursement per year ($5,700 part-time) · $10,000 Student Loan Repayment ($5,000 part-time) · $1,000 Professional Development per year ($500 part-time) · $250 Wellbeing Fund per year($125 for part-time) · Annual Employee Merit Increase and Incent ...

  • Northwestern Medicine

    Regulatory Affairs Specialist

    1 week ago

    Northwestern Medicine Chicago, United States

    Benefits$10,000 Tuition Reimbursement per year ($5,700 part-time)$10,000 Student Loan Repayment ($5,000 part-time)$1,000 Professional Development per year ($500 part-time)$250 Wellbeing Fund per year($125 for part-time)Annual Employee Merit Increase and Incentive BonusPaid time o ...

  • Northwestern Medicine

    Regulatory Affairs Specialist

    3 days ago

    Northwestern Medicine Chicago, United States

    Benefits · $10,000 Tuition Reimbursement per year ($5,700 part-time) · $10,000 Student Loan Repayment ($5,000 part-time) · $1,000 Professional Development per year ($500 part-time) · $250 Wellbeing Fund per year($125 for part-time) · Annual Employee Merit Increase and Incentive B ...

  • DivIHN Integration

    Specialist Regulatory Affairs

    1 week ago

    DivIHN Integration Green Oaks, United States

    DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 200 ...

  • DivIHN Integration

    Specialist Regulatory Affairs

    6 days ago

    DivIHN Integration North Chicago, United States

    DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 200 ...

  • Metropolitan Water Reclamation District of Greater Chicago

    Public Affairs Specialist

    4 days ago

    Metropolitan Water Reclamation District of Greater Chicago Chicago, United States

    General Statement · Under direction, performs a variety of public information assignments including developing and writing press releases, talking points, presentations, fact sheets, and social media messages, and graphic design. · Essential Job Functions · Essential job functi ...

  • Spectraforce

    Regulatory Affairs Specialist

    1 week ago

    Spectraforce Round Lake, United States

    Title: Regulatory Affairs Ops Specialist · Duration: 12 Months · Location: Round LakeIL, 60073 · Hybrid - 3 days onsite, 2 remote · Description: · Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types · Cr ...