Jobs
>
Minneapolis

    Sr. Regulatory Affairs Specialist - Minneapolis, United States - Taleo

    Taleo
    Taleo Minneapolis, United States

    2 weeks ago

    Default job background
    Description

    Position Description:
    Sr. Regulatory Affairs Specialist for Medtronic, Inc.

    Minneapolis, MN. Multiple positions available.

    Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapies to markets worldwide.

    Assess the regulatory impact of changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy.

    Prepare document packages for regulatory submissions from all areas of company and inspections for FDA Quality Systems Regulation (QSR). Compile all materials required in submissions, license renewal and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance. Work on PMA (Pre-Market Approval) or 510(k) submissions for US Class III or Class II medical devices.


    Work on MDD (Medical Device Directive) design dossiers, MDR (Medical Device Regulation) technical files and change notifications or Design History Files.

    Responsible for total product life-cycle regulatory activities to include pre-clinical, clinical, approval and post-approval.

    Navigate complex government and industry regulations to include US Food Drug and Cosmetic Act and relevant MDR to include 21 CFR Parts 11, 803, 806, 807, 814, 822, 830, and 860.


    Ensure product adherence to Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive (EU MDD 93/42/EEC), Canadian Medical Device Regulation (CMDR), ISO 13485 and ISO Position is open to telecommuting from anywhere in the United States.

    #LI-DNI.


    Basic Qualifications:


    Master's degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field and 2 years' experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation; OR Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field and 5 years' experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation.

    Must possess at least 2 years of experience with each of the following:
    Pre-Market Approval or 510(k) submissions for US Class III or Class II medical devices; MDD design dossiers, MDR technical files and change notifications, or Design History Files; Total product life-cycle regulatory activities to include pre-clinical, clinical, approval and post-approval; 21 CFR Parts 11, 803, 806, 807, 814, 822, 830, and 860; QSR 21 CFR 820, EU MDD 93/42/EEC, CMDR, ISO 13485, and ISO

    Additional Information


    Posting Date:
    Apr 22, 2024


    Travel:
    No

    Salary Min: 101,400

    Salary Max: 129,000

    #J-18808-Ljbffr
  • AtriCure

    Regulatory Affairs Specialist

    2 days ago

    AtriCure Minneapolis, United States

    AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reductio ...

  • Laborie

    Senior Regulatory Affairs Specialist

    2 weeks ago

    Laborie Plymouth, United States

    We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like ...

  • Taleo

    Sr. Regulatory Affairs Specialist

    1 week ago

    Taleo Minneapolis, United States

    Position Description:Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapi ...

  • Medtronic

    Sr. Regulatory Affairs Specialist

    1 day ago

    Medtronic Minneapolis, United States

    Position Description · Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and ther ...

  • Medtronic

    Sr. Regulatory Affairs Specialist

    1 week ago

    Medtronic Minneapolis, United States

    Position Description:Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapi ...

  • Medtronic

    Sr. Regulatory Affairs Specialist

    2 weeks ago

    Medtronic Minneapolis, United States

    Position Description:Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapi ...

  • Medtronic

    Sr. Regulatory Affairs Specialist

    1 week ago

    Medtronic Minneapolis, United States

    Position Description: · Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and ther ...

  • Laborie

    Senior Regulatory Affairs Specialist

    2 weeks ago

    Laborie Minneapolis, United States

    We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters its what fuels our motivation and contributes to our success. If youre ready to make a positive impact in the lives of patients across the globe, wed like to me ...

  • Laborie

    Senior Regulatory Affairs Specialist

    1 week ago

    Laborie Minneapolis, United States

    We believe that great healthcare is an essential safeguard of human dignity. · At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd li ...

  • Laborie

    Senior Regulatory Affairs Specialist

    2 weeks ago

    Laborie Minneapolis, United States

    We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters its what fuels our motivation and contributes to our success. If youre ready to make a positive impact in the lives of patients across the globe, wed like to me ...

  • Coloplast

    Senior Regulatory Affairs Specialist

    12 hours ago

    Coloplast Minneapolis, United States

    Coloplast Corp. · Senior Regulatory Affairs Specialist · Minneapolis , · Minnesota · Apply Now · Senior Regulatory Affairs Specialist Location: Minneapolis, MN, US Job Family: Country/Region: United States The Senior Regulatory Affairs Specialist is responsible for complaint ...

  • Medtronic

    Senior Regulatory Affairs Specialist

    1 week ago

    Medtronic Minneapolis, United States

    Senior Regulatory Affairs Specialist - Peripheral Vascular Health (hybrid) · Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. · We challenge ou ...

  • Medtronic

    Senior Regulatory Affairs Specialist

    1 week ago

    Medtronic Minneapolis, United States

    The person in this role may work remotely within the US or onsite at a US-based Medtronic facility. · CAREERS THAT CHANGE LIVES · The strategic intent of the newly designed Global Operations and Supply Chain (GO&SC) Operating Unit is to create a more agile and responsive manufact ...

  • Medtronic

    Senior Regulatory Affairs Specialist

    3 weeks ago

    Medtronic Minneapolis, United States

    Senior Regulatory Affairs Specialist - Peripheral Vascular Health (hybrid) · Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourse ...

  • Abbott Laboratories company

    Regulatory Affairs Specialist II

    12 hours ago

    Abbott Laboratories company Minneapolis, United States

    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 ...

  • Bio-Techne

    Advanced Regulatory Affairs Specialist

    2 weeks ago

    Bio-Techne Minneapolis, United States

    **By joining the Bio-Techne team, you will have an impact on future cutting-edge research. Bio-Techne andall ofits brands provides tools for researchers in Life Sciences and Clinical Diagnostics.** · **Position Summary:** · The Advanced Regulatory Affairs Specialist provides in ...

  • Inspire Medical Systems I

    Sr. Regulatory Affairs Specialist

    3 hours ago

    Inspire Medical Systems I Minneapolis, United States

    Job Description · Job Description · ABOUT INSPIRE MEDICAL SYSTEMS · Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved med ...

  • Inspire Medical Systems I

    Sr. Regulatory Affairs Specialist

    3 days ago

    Inspire Medical Systems I Minneapolis, United States

    Job Description · Job DescriptionABOUT INSPIRE MEDICAL SYSTEMS · Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical ...

  • TE Connectivity

    regulatory affairs specialist iii

    1 week ago

    TE Connectivity Minneapolis, United States

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. · Job Overview · Regulatory Affairs oversees compliance activities for customers. This covers reporting, tracking and impr ...

  • TE Connectivity

    regulatory affairs specialist iii

    1 week ago

    TE Connectivity Minneapolis, United States

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.Job OverviewRegulatory Affairs oversees compliance activities for customers. This covers reporting, tracking and improving co ...