Current jobs related to Medical Device Regulatory Associate - minneapolis - Planet Pharma

  • Medical Device Manufacturing Specialist

    3 days ago

    Minneapolis, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Job Summary:Cretex Medical Component and Device Technologies is seeking a skilled Medical Device Manufacturing Specialist to join our team. As a key member of our manufacturing team, you will be responsible for assembling prototypes, executing test protocols, and documenting results.Responsibilities:Provide technical support to operations teamsCollaborate...

  • International Regulatory Affairs Specialist

    3 weeks ago

    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...

  • Medical Device Operator

    4 weeks ago

    Minneapolis, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Operator Assembler III Job SummaryCretex Medical Component and Device Technologies is seeking a skilled Operator Assembler III to join our team. As a key member of our production team, you will be responsible for operating and tending specified equipment and machines to create precision components and devices for the medical industry.Responsibilities:Inspect...

  • Medical Device Operator

    2 weeks ago

    Minneapolis, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Job Title: Medical Device OperatorCretex Medical Component and Device Technologies is seeking a skilled Medical Device Operator to join our team. As a Medical Device Operator, you will be responsible for operating and tending specified equipment and machines to create parts or products for the medical device industry.Responsibilities:Inspect, trim, clean,...

  • Medical Device Manufacturing Specialist

    2 weeks ago

    Minneapolis, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    About Cretex Medical Component and Device TechnologiesCretex Medical Component and Device Technologies is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping, and device assembly.Job SummaryThe...

  • Medical Device Assembly Technician

    7 days ago

    Minneapolis, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    About Cretex Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry.Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly.The Medical Device Assembly Technician is responsible for operating and tending...

  • Medical Device Manufacturing Specialist

    1 week ago

    Minneapolis, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    **Job Summary**Cretex Medical Component and Device Technologies is seeking a skilled Medical Device Manufacturing Specialist to join our team. As a key member of our manufacturing team, you will be responsible for assembling prototypes, executing test protocols, and documenting results.**Responsibilities**Provide technical support to manufacturing...

  • Medical Device Assembly Specialist

    1 month ago

    Minneapolis, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Job SummaryCretex Medical Component and Device Technologies is seeking a skilled Operator Assembler III to join our team. As a key member of our production team, you will be responsible for operating and tending specified equipment and machines to create precision components and assemblies for the medical device industry.ResponsibilitiesInspect, trim, clean,...

  • Medical Device Operator Assembler III

    2 weeks ago

    Minneapolis, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Job SummaryCretex Medical Component and Device Technologies is seeking a skilled Operator Assembler III to join our team. As a key member of our production team, you will be responsible for operating and tending specified equipment and machines to create precision components and assemblies for the medical device industry.ResponsibilitiesInspect, trim, clean,...

  • Medical Device Operator Assembler III

    2 weeks ago

    Minneapolis, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Job Title: Operator Assembler IIICretex Medical Component and Device Technologies is seeking a skilled Operator Assembler III to join our team. As a key member of our production team, you will be responsible for operating and tending specified equipment and machines to create precision components and assemblies for the medical device...

  • Technical Lead

    2 weeks ago

    Minneapolis, Minnesota, United States Luminary Group Full time

    Job OpportunityLuminary Group is seeking a highly skilled and motivated Technical Lead to join our team for a 6-month full-time engagement with a leading medical device company based in the USA.Key ResponsibilitiesProvide technical expertise and guidance to the development team, ensuring the successful delivery of medical device projects.Collaborate with...

  • Quality Systems Engineer

    2 days ago

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

    About This RoleThe Quality Systems Engineer will play a critical role in ensuring the effectiveness of Inspire Medical Systems' Quality Management System. This position will specialize in training, providing leadership by educating employees on core quality principles, and driving a continuous learning environment. The successful candidate will have a strong...

  • Medical Device Quality Assurance Specialist

    4 weeks ago

    Minneapolis, Minnesota, United States Intellectt Inc Full time

    Job Title: Medical Device TesterAt Intellectt Inc, we are seeking a highly skilled Medical Device Tester to join our team. As a Medical Device Tester, you will be responsible for performing tests on medical devices, ensuring their quality and safety.Key Responsibilities:Perform thorough testing of medical devices, including mechanical, electrical, and visual...

  • Medical Device Assembler

    2 weeks ago

    Minneapolis, Minnesota, United States Aerotek Full time

    Job SummaryAerotek is seeking a skilled Medical Device Assembler to join our team in SAINT PAUL, MN. As a Medical Device Assembler, you will be responsible for the production of high-quality medical devices within a manufacturing cell. This is a Contract-to-Hire position with a duration of 6 Month(s).Key ResponsibilitiesPerform a combination of assembly,...

  • Medical Device Assembler

    4 days ago

    Minneapolis, Minnesota, United States Laborie Medical Technologies Corp Full time

    Key Responsibilities:As a key member of the Operations team at Laborie Medical Technologies Corp, the Medical Device Assembler will be responsible for assembling, inspecting, and packaging the company's medical device products. This role requires attention to detail, quality control, and a commitment to delivering high-quality products.About the Role:The...

  • Medical Device Program Architect

    2 weeks ago

    Minneapolis, Minnesota, United States Luminary Group LLC Full time

    Program Architect for Medical Device DevelopmentLuminary Group LLC is seeking a highly skilled and experienced Program Architect to lead the development and implementation of medical device programs. As a Program Architect, you will be responsible for providing technical leadership and strategic direction to ensure the successful delivery of medical device...

  • Senior Software Architect for Medical Devices

    2 months ago

    Minneapolis, Minnesota, United States Luminary Group LLC Full time

    Job DescriptionLuminary Group LLC is seeking a highly skilled and experienced Program Architect to join our team in the medical device industry.Key Responsibilities:Technical Leadership: Provide technical guidance and strategic direction for the development and implementation of medical device programs.Program Architecture: Lead the architectural design and...

  • Medical Device Quality Assurance Specialist

    4 weeks ago

    Minneapolis, Minnesota, United States Intellectt Inc Full time

    Job Title: Medical Device TesterAt Intellectt Inc, we are seeking a highly skilled Medical Device Tester to join our team. As a Medical Device Tester, you will be responsible for performing tests on medical devices, ensuring their quality and safety.Key Responsibilities:Perform thorough testing of medical devices, including mechanical, electrical, and visual...

  • International Regulatory Affairs Specialist

    3 weeks ago

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

    About Inspire Medical SystemsInspire 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 SummaryWe are...

  • Program Architect

    2 months ago

    Minneapolis, Minnesota, United States Luminary Group LLC Full time

    Job DescriptionLuminary Group LLC is seeking a highly skilled and experienced Program Architect to join our team in the medical device industry.Key ResponsibilitiesTechnical Leadership: Provide technical leadership and strategic direction for the development and implementation of medical device programs.Program Design and Development: Lead the architectural...

Medical Device Regulatory Associate

2 months ago

minneapolis, United States Planet Pharma Full time

In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for company products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.

Neuroscience

The Neuroscience Portfolio group develops life-restoring therapies and healthcare solutions that span the neurological care continuum including integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

A Day in the Life

Responsibilities include the following but not limited to:

  • Apply policies and procedures to comply with FDA and OUS regulations.
  • Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
  • Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
  • Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
  • Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
  • Maintain awareness of new products, government regulations and requirements.
  • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
  • Other duties as assigned.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelor degree
  • High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc)
  • 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation

Nice to Have

  • Degree in Health Care, Sciences, or Bio-Medical Engineering
  • Medical device industry experience
  • Strong verbal and written communication skills
  • Knowledge of basic anatomy and physiology
  • Strong attention to detail
  • High level of computer proficiency