Jobs
>
Schaumburg

    Medical Devices- Associate Regulatory Affair - Schaumburg, United States - ULDQS, Inc.

    ULDQS, Inc.
    ULDQS, Inc. Schaumburg, United States

    3 weeks ago

    Default job background
    Description
    JOB OBJECTIVES:

    Assist RAM in managing the provision of certification services related to regulatory requirements in the medical device sector. Support the DQS RAM in respect to the MDSAP and ISO 13485 clients seeking certification via DQS MED Notified Body in Germany. Support the DQS Inc. US Medical Sales team in sales verification reviews prior to the New Business creation. Help to strengthen the US Medical Team as we continue to add new clients working alongside RAM.

    ESSENTIAL FUNCTIONS:
    • Basic knowledge in certification of management systems.
    • Basic knowledge of the applicable standards, guidelines and specifications for accreditation including the requirements for notification and for designation and the specification documents applicable in this context and relevant specifications (e.g. IMDRF, MDSAP documents)
    • Understanding/Growth potential in project management.
    • Basic Knowledge of the relevant standards for certification of medical devices and management systems for manufacturer of medical products (EN ISO 13485,
    MDSAP) as well as the role for the certification authority.
    • Basic knowledge base of technologies in the field of products as well as design and manufacturing of products
    • Demonstration of neutrality, impartiality, and freedom from personal interest during the review and evaluation of assessment reports
    • Responsible for New MDSAP/ISO 13485 Clients signing up and working towards managing current clients.
    • Supporting Sales on review of New Business and completeness of Initial Sales Paperwork.
    • Managing the requests on Transfers to other Notified Bodies from Sales
      • Audit Reports
      • Complaint Data requests
    • Train and Learn requirements of DQS Med.
    • Assist in maintaining and improving current processes/procedures.
    • Support assigning training auditors to audits.
    • Perform other duties as assigned.
    EXPERIENCE/EDUCATION REQUIRED:
    • HS Diploma min., Bachelors preferred but not required.
    • Computer Skills: Microsoft Office - Excel, Word, PowerPoint, Outlook, Teams etc.
    • Must be flexible and be willing to work beyond standard work hours as needed.
    • Ability to work productively in teams.
    • Strong analytical skills.
    • Strong interpersonal and communication skills.
    • Ability to travel domestically primarily and internationally occasionally.
    DQS Inc. is an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled
  • McCain Foods USA, Inc.

    Regulatory Affairs Specialist

    3 weeks 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 ...

  • Validation Associates

    Regulatory Affairs Associate

    3 weeks ago

    Validation Associates North Chicago, United States

    **Description**: · **Accountability / Scope**: · - As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. · - Individual shall develop partne ...

  • Validation Associates

    Regulatory Affairs Associate

    3 weeks ago

    Validation Associates North Chicago, United States

    **Description**: · **Accountability / Scope**: · - As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. · - Individual shall develop partne ...

  • Northwestern Memorial Healthcare

    Regulatory Affairs Specialist

    1 day ago

    Northwestern Memorial Healthcare Chicago, United States

    **Company Description** · At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you'll have the opportu ...

  • Bel Brands USA

    Regulatory Affairs Manager-Bel Chicago

    3 weeks ago

    Bel Brands USA Itasca, United States

    Country: United States · City: Chicago · Job Family: Quality Regulations Expertise · Contract Type: Unlimited-term · Job ID: 50711 · Regulatory Affairs Manager-Bel Chicago · Bel, makers of iconic cheese brands including Babybel, The Laughing Cow, Boursin and GoGosqueeZ, is a grow ...

  • Abbott Laboratories

    Manager Regulatory Affairs

    4 weeks ago

    Abbott Laboratories Des Plaines, United States Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...

  • Verano

    Director of Regulatory Affairs

    3 days ago

    Verano Chicago, United States

    Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry's leading companies based on historical revenue, geographic scope, and brand performance, is a vertically integrated, multi-state operator. Verano's active operations span 13 U.S. states, comprise ...

  • GForce Life Sciences

    Regulatory Affairs Specialist

    3 weeks 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 ...

  • Northwestern Memorial Healthcare

    Regulatory Affairs Specialist

    1 day ago

    Northwestern Memorial Healthcare Chicago, United States Full time

    Job Description · The Regulatory Affairs Specialist reflects the mission, vision, and values of NM, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accredit ...

  • Planet Pharma

    Regulatory Affairs Associate

    3 weeks ago

    Planet Pharma North Chicago, United States

    Accountability / Scope: · As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. · Individual shall develop partnership with other regulatory ...

  • Astellas

    Associate Director, Regulatory Affairs Advertising

    3 weeks ago

    Astellas Northbrook, United States

    **Purpose and Scope**: · Responsible for performing regulatory review of advertising and promotional materials for Astellas in the US. Provides expertise with respect to the requirements for promotional materials as set forth by FDA. Advises teams on best practices regarding plan ...

  • AbbVie

    Manager Regulatory Affairs, in Vitro Diagnostics

    2 weeks ago

    AbbVie Chicago, United States

    **Company Description** · The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business ...

  • INTELLECTT INC

    Regulatory Affairs

    3 weeks ago

    INTELLECTT INC Chicago, United States

    Role : Regulatory Affairs AssociateDuration : 8 MonthsJob Descriptionresponsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.authoring and submitting PMA supplements ( ...

  • Collabera

    Regulatory Affairs Associate

    11 hours ago

    Collabera Lake Forest, United States

    Home · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Lake Forest, Illinois, US · Salary: $30.00 Per Hour · Job Code: · End Date: · Days Left: 10 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitra ...

  • Collabera

    Regulatory Affairs Associate

    11 hours ago

    Collabera North Chicago, United States

    Home · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 7 days, 3 hours left · Apply · To discuss more about this job opportunity, pl ...

  • INTELLECTT INC

    Regulatory Affairs

    3 weeks ago

    INTELLECTT INC Chicago, United States

    Role : Regulatory Affairs Associate · Duration : 8 Months · Job Description · responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. · authoring and submitting P ...

  • Collabera

    Regulatory Affair Specialist

    1 week ago

    Collabera Lake Forest, United States

    Home · Search Jobs · Job Description · Regulatory Affair Specialist · Contract: Lake Forest, Illinois, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 6 days, 3 hours left · Apply · Job Description: · RESPONSIBILITIES:Responsible for technical writing ...

  • Collabera

    Regulatory Affairs Associate

    1 week ago

    Collabera Lake Forest, United States

    Home · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Lake Forest, Illinois, US · Salary: $30.00 Per Hour · Job Code: · End Date: · Days Left: 21 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitra ...

  • Rush-Copley Medical Center

    Coordinator, Regulatory Affairs

    1 week ago

    Rush-Copley Medical Center Aurora, United States

    Position Summary:# The Coordinator of Regulatory Affairs leads and coordinates the organization-wide compliance with regulatory requirements established by the Centers for Medicare and Medicaid Services, Illinois Department of Public Health, The Joint Commission and other pertine ...

  • Rush-Copley Medical Center

    Coordinator, Regulatory Affairs

    1 hour ago

    Rush-Copley Medical Center Aurora, United States

    Position Summary : The Coordinator of Regulatory Affairs leads and coordinates the organization-wide compliance with regulatory requirements established by the Centers for Medicare and Medicaid Services, Illinois Department of Public Health, The Joint Commission and other pertine ...