Jobs
>
Minneapolis

    Sr. Regulatory Affairs Specialist - Minneapolis, United States - Inspire Medical Systems I

    Inspire Medical Systems I
    Inspire Medical Systems I Minneapolis, United States

    3 weeks ago

    Default job background
    Description
    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 medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP.

    Our focus on patient outcomes is at the core of everything we do, and our "think I can" attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

    WHY JOIN OUR FAST-GROWING TEAM
    At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community.

    We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

    If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team


    ABOUT THIS POSITION
    We are recruiting a

    Sr. Regulatory Affairs Specialist

    to join Inspire Medical Systems located in Minneapolis, MN. In this role, you will be a member of a small, cross functional team focusing on a strategic initiative. It will be a fast-paced environment where you will contribute to multiple different roles.


    OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
    Evaluate international geographic requirements for clinical studies and select geographies that align with Inspire's strategic goals
    Interact directly with FDA and international regulatory agencies to author submissions and coordinate with the governing body for clinical studies

    Work with technical experts in product development, quality, and clinical to generate project deliverables and to address questions from regulatory agencies.

    Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.

    WHAT YOU CAN BRING TO OUR GREAT TEAM


    Required:
    Bachelor's degree
    5+ years minimum experience in medical device industry
    Demonstrated team leadership skills and ability to prioritize, execute and report on projects
    Ability to work on multiple tasks concurrently with changing priorities


    Preferred:
    Regulatory Submission Experience (FDA, EU, PMDA, TGA)
    Degree in scientific or technical field
    10+ years minimum experience in medical device industry


    Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state, and local laws.

    This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs.

    Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities.

    All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

    Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce.
    Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at or email

    (dot)com

    Inspire Medical Systems participates in E-Verify.

    #J-18808-Ljbffr
  • Medtronic

    Regulatory Affairs Specialist

    1 week ago

    Medtronic Minneapolis, United States

    Careers that Change Lives · Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chronic pain and engineered the first deep brain stimulation (DBS) system to treat movement disorders and the first implantable drug ...

  • Philips North America

    Senior Regulatory Affairs Specialist

    1 week ago

    Philips North America Minneapolis, United States

    Job TitleSenior Regulatory Affairs Specialist · Job Description Looking at the challenges the world is facing today Philips purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, youll be working towards creating a better and f ...

  • Philips International

    Senior Regulatory Affairs Specialist

    3 days ago

    Philips International Minneapolis, United States

    Senior Regulatory Affairs Specialist page is loaded · Senior Regulatory Affairs Specialist · Apply · locations · Plymouth · time type · Full time · posted on · Posted 12 Days Ago · job requisition id · 526894 · Job Title Senior Regulatory Affairs Specialist Job Descrip ...

  • Abbott

    Regulatory Affairs Specialist II

    1 week ago

    Abbott 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

    1 week ago

    Bio-Techne Minneapolis, United States

    Job Details · Level: Experienced · Job Location: Minneapolis MN - Minneapolis, MN · Position Type: Full Time · Education Level: Bachelor's Degree · Salary Range: Undisclosed · Travel Percentage: Negligible · Job Shift: Day · Job Category: Quality & Regulatory · Description · By j ...

  • Abbott Laboratories

    Senior Regulatory Affairs Specialist

    3 days ago

    Abbott Laboratories 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 ...

  • Inspire Medical Systems I

    Sr. Regulatory Affairs Specialist

    2 weeks ago

    Inspire Medical Systems I Minneapolis, United States

    Job Description Job Description ABOUT INSPIRE MEDICAL SYSTEMSInspire 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 devi ...

  • Bio-Techne

    Advanced Regulatory Affairs Specialist

    4 days 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 weeks 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 ...

  • Abbott

    Senior Regulatory Affairs Specialist

    1 week ago

    Abbott 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 ...

  • Philips

    Senior Regulatory Affairs Specialist

    1 week ago

    Philips Minneapolis, United States

    Looking at the challenges the world is facing today Philips purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, youll be working towards creating a better and fairer future for all. · In this role you have the opportunity to ...

  • National Black MBA Association

    Senior Regulatory Affairs Specialist

    1 week ago

    National Black MBA Association Minneapolis, United States

    Job TitleSenior Regulatory Affairs SpecialistJob Description Looking at the challenges the world is facing today Philips purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, youll be working towards creating a better and faire ...

  • Inspire Medical Systems

    Senior Principal Regulatory Affairs Specialist

    1 week ago

    Inspire Medical Systems Minneapolis, United States

    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 medical device, designed to reduce OSA seve ...

  • Medtronic

    RF Principal Regulatory Affairs Specialist

    1 week ago

    Medtronic Minneapolis, United States

    Careers that Change LivesWe believe that when people from different cultures, genders, and points of view come together, innovation is the result and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.Pelvic Health is part of the Neuroscie ...

  • Medtronic

    RF Principal Regulatory Affairs Specialist

    3 weeks ago

    Medtronic Minneapolis, United States

    Careers that Change Lives · We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. · Pelvic Health is part of the ...

  • Medtronic

    RF Principal Regulatory Affairs Specialist

    1 week ago

    Medtronic Minneapolis, United States

    Careers that Change Lives · We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. · Pelvic Health is part of the ...

  • Custom Search

    Sr. Regulatory Affairs Specialist

    2 weeks ago

    Custom Search Minneapolis, United States

    Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team The Sr. Regulatory Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-regi ...

  • Philips

    Principal Regulatory Affairs Specialist-CT/AMI

    3 days ago

    Philips Minneapolis, United States

    The Principal RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmapsunderstanding competitive claim la ...

  • Coloplast

    Senior Regulatory Affairs Specialist

    3 weeks 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 ...

  • Abbott Laboratories company

    Regulatory Affairs Specialist II

    3 weeks 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 ...