International Regulatory Affairs Specialist

4 days ago


Minneapolis, Minnesota, United States Inspire Medical Systems I Full time
About Inspire Medical Systems

Inspire Medical Systems is a pioneering company in the medical device industry, dedicated to revolutionizing the treatment of obstructive sleep apnea (OSA). Our innovative technology has made a significant impact in the lives of those living with OSA, and we continue to push the boundaries of what is possible.

Job Summary

We are seeking an International Regulatory Affairs Specialist to join our team. This role will provide regulatory support for implantable neurostimulation therapy for the treatment of OSA, focusing on manufacturing and design change assessments and vigilance activities for Asia Pacific geographies.

Key Responsibilities
  • Coordinate regulatory assessments of design and manufacturing changes, e.g., engineering change orders and supplier change requests.
  • Work with technical experts in product development, quality, and clinical to address questions from regulatory agencies.
  • Document field reports and complaints for regulatory reporting.
  • Interact with international regulatory partners in local offices to support submission contents, as well as foreign regulatory agency reviewers to answer questions.
  • Review labeling and promotional material for regulatory compliance.
Requirements
  • Bachelor's degree
  • International work and/or educational experience. Adaptability to international business cultures.
  • Writing and communication skills.
Preferred Qualifications
  • Medical device industry experience, in regulatory, quality, and/or engineering.
  • Education and/or work experience in a technical or scientific field.
  • Complaint handling and/or post-market change assessment experience.
  • Foreign language ability, preferably in Asian geography.


  • Minneapolis, Minnesota, United States Custom Search Full time

    Job Title: Sr. International Regulatory Affairs SpecialistOur mid-sized medical client is seeking a highly skilled Sr. Regulatory Affairs Specialist to join their team. The successful candidate will be responsible for ensuring product approvals are properly maintained and product re-registrations are properly managed.Key Responsibilities:Prepare...


  • Minneapolis, Minnesota, United States Medtronic Full time

    About the RoleWe are seeking a highly skilled Senior Principal Regulatory Affairs Specialist to join our team at Medtronic. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements in the US and EU.Key ResponsibilitiesDevelop and implement global...


  • Minneapolis, Minnesota, United States Randstad Life Sciences Full time

    Job Title: Regulatory Affairs SpecialistJoin our team at Randstad Life Sciences as a Regulatory Affairs Specialist, where you will play a crucial role in ensuring compliance with regulatory requirements and maintaining a strong reputation in the industry.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to support our daily operations,...


  • Minneapolis, Minnesota, United States Abbott Laboratories Full time

    Join Abbott Laboratories as a Regulatory Affairs Specialist IIAt Abbott Laboratories, we're committed to advancing the treatment of heart disease through breakthrough medical technologies. As a Regulatory Affairs Specialist II, you'll play a critical role in ensuring our products and procedures comply with regulatory agency specifications.Key...


  • Minneapolis, Minnesota, United States Abbott Laboratories Full time

    Job Title: Senior Regulatory Affairs SpecialistAbbott Laboratories 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 medicines.We are seeking...


  • Minneapolis, Minnesota, United States Randstad Full time

    Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Randstad. As a key member of our life sciences team, you will be responsible for ensuring compliance with regulatory requirements and providing expert guidance on regulatory strategies.As a Regulatory Affairs Specialist II, you will be responsible for:Supporting...


  • Minneapolis, Minnesota, United States Abbott Laboratories Full time

    Job OpportunityAbbott Laboratories is seeking a highly skilled Regulatory Affairs Specialist II to join our team in Plymouth, MN. As a key member of our Electrophysiology business, you will play a critical role in advancing the treatment of heart disease through breakthrough medical technologies.Key ResponsibilitiesPrepare and submit regulatory applications,...


  • Minneapolis, Minnesota, United States Inspire Medical Systems I Full time

    Company OverviewINSPIRE MEDICAL SYSTEMSInspire Medical Systems is at the forefront of the medical industry, focused on improving the lives of individuals affected by Obstructive Sleep Apnea (OSA). Our groundbreaking FDA-approved device is designed to reduce the severity of OSA for those who have not found consistent relief through CPAP therapy. We are...


  • Minneapolis, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott 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 medicines.Job SummaryWe are seeking a highly skilled...


  • Minneapolis, Minnesota, United States Abbott Laboratories company Full time

    About Abbott LaboratoriesAbbott 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 medicines.Job SummaryWe are seeking a highly skilled...


  • Minneapolis, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott 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 medicines.Our MissionWe are committed to helping people live...


  • Minneapolis, Minnesota, United States Volt Full time

    Regulatory Affairs Specialist IIVolt is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and maintaining a strong regulatory posture.Key Responsibilities:Support daily Regulatory Affairs function, including...


  • Minneapolis, Minnesota, United States Volt Full time

    Job Title: Regulatory Affairs Specialist IIVolt is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and providing expert guidance on regulatory matters.Key Responsibilities:Support daily Regulatory Affairs function,...


  • Minneapolis, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott 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 medicines.Our MissionWe are committed to delivering...


  • Minneapolis, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories 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 medicines.Our MissionWe are committed to...


  • Minneapolis, Minnesota, United States Inspire Medical Systems I Full time

    Job DescriptionAbout Inspire Medical SystemsInspire Medical Systems is a pioneering medical device company that has revolutionized the sleep industry with its FDA-approved medical device for treating Obstructive Sleep Apnea (OSA). Our mission is to make a positive impact on the lives of individuals living with OSA, and we are committed to delivering...


  • Minneapolis, Minnesota, United States The Judge Group Full time

    Job SummaryThe Judge Group is seeking a highly skilled Regulatory Affairs Specialist to join our team on a 12 month contract basis. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and providing expert support to our clients.Key ResponsibilitiesSupport daily Regulatory Affairs function,...


  • Minneapolis, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories 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 medicines. Our 114,000 colleagues serve people...


  • Minneapolis, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a global healthcare leader that empowers individuals to live their best lives. Our diverse portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.Our MissionWe are committed to...


  • Minneapolis, Minnesota, United States Compunnel Inc. Full time

    Job SummaryCompunnel Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and providing regulatory expertise to support business growth.Key ResponsibilitiesRegulatory Compliance: Ensure compliance with regulatory...