Senior Regulatory Affairs Specialist

3 weeks ago


Minneapolis, United States Laborie Medical Technologies Corp Full time
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 to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We're not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We're Looking For:

Laborie Medical Technologies is currently searching for a Senior Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific Laborie Medical products and ensures compliance with required regulations and established corporate standards.

How you contribute:
  • Preparing documentation for international regulatory registrations and renewals.
  • Defining worldwide regulatory requirements necessary for regulatory approval of assigned products.
  • Executing product submission strategies as directed.
  • Maintaining all regulatory documentation to ensure availability for external audits and preparation of submission packages.
  • Maintaining a thorough knowledge of current regulatory requirements.
  • Executing on additional responsibilities as defined by management.
Qualifications:
  • Bachelor's Degree in Science, Engineering, or other relevant discipline and 4+ years' experience in Regulatory Affairs in the medical device industry.
  • Working knowledge of quality system regulations and guidelines.
  • Great communication skills with all levels of personnel.
  • High level of organization and planning skills.
  • Working knowledge of medical devices, procedures, and terminology.

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

•Paid time off and paid volunteer time

•Medical, Dental, Vision and Flexible Spending Account

•Health Savings Account with Company Funded Contributions

•401k Retirement Plan with Company Match

•Parental Leave and Adoption Services

•Health and Wellness Programs and Events

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.

  • Minneapolis, United States Laborie Full time

    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 to meet you. We support and empower our employees to grow their careers...


  • Minneapolis, United States Laborie Full time

    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 meet you. We support and empower our employees to grow their careers in an...


  • Minneapolis, United States Coloplast Full time

    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 assessment and complaint reporting. This position will also prepare, monitor and communicate...


  • Minneapolis, United States Bio-Techne Full time

    **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 independent support to senior regulatory staff to submit regulatory filings. This...


  • Minneapolis, United States Custom Search Full time

    Our mid-sized client is adding a Regulatory Affairs Specialist 2 to join their team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform...


  • Minneapolis, United States Threadneedle group Full time

    We have an exciting opportunity at Ameriprise as a Regulatory Affairs Analyst! This position is part of a team that provides day-to-day operational support to the Regulatory Affairs team in managing regulatory exams, inquiries and internal investigations. This includes matter intake, production fulfillment, logistical support, records management, metrics...


  • Minneapolis, United States Stryker Full time

    Work Flexibility: Hybrid Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts...


  • Minneapolis, United States UnitedHealth Group Full time

    At UnitedHealthcare, we're simplifying the health care experience, creating healthier communities and removing barriers to quality care. The work you do here impacts the lives of millions of people for the better. Come build the health care system of tomorrow, making it more responsive, affordable and equitable. Ready to make a difference? Join us to start...


  • Minneapolis, United States Interrad Medical Full time

    The Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Medical. This position will provide hands on leadership, tactical implementation, follow-up, and documentation that demonstrates that the quality system is...

  • Director of Quality

    4 days ago


    Minneapolis, United States Lumicity Full time

    **Director of Quality and Regulatory Affairs (Medical Devices)** **Position Overview:** As the Director of Quality and Regulatory Affairs in the medical device industry, you will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality standards, and driving continuous improvement initiatives. You will lead a team in...

  • Director of Quality

    2 days ago


    Minneapolis, United States Lumicity Full time

    **Director of Quality and Regulatory Affairs (Medical Devices)** **Position Overview:** As the Director of Quality and Regulatory Affairs in the medical device industry, you will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality standards, and driving continuous improvement initiatives. You will lead a team in...

  • Director of Quality

    7 days ago


    Minneapolis, United States Lumicity Full time

    **Director of Quality and Regulatory Affairs (Medical Devices)****Position Overview:**As the Director of Quality and Regulatory Affairs in the medical device industry, you will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality standards, and driving continuous improvement initiatives. You will lead a team in...

  • Director of Quality

    7 days ago


    Minneapolis, United States Lumicity Full time

    **Director of Quality and Regulatory Affairs (Medical Devices)****Position Overview:**As the Director of Quality and Regulatory Affairs in the medical device industry, you will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality standards, and driving continuous improvement initiatives. You will lead a team in...


  • Minneapolis, United States Abbott Laboratories Full time

    Job TitleManager Medical Affairs & GrantsWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the...


  • Minneapolis, Minnesota, United States Xcel Energy Full time

    Are you looking for an exciting job where you can put your skills and talents to work at a company you can feel proud to be a part of? Do you want a workplace that will challenge you and offer you opportunities to learn and grow? A position at Xcel Energy could be just what you're looking for.Position SummaryWork directly with senior management to develop...


  • Minneapolis, United States The Fountain Group Full time

    Title:Regulatory Windchill Coordinator Location: Plymouth, MN Pay: $15 - $27/hr Description: Working with Group that releases products to US, Indonesia, Egypt, Singapore etc Recieve request and go through spreadsheets/database to ensure correct Part # - send out approvals, and follow check list for the Product Release. All of this is within Systems Provides...


  • Minneapolis, United States Bridgewater Bank Full time

    We are seeking a meticulous and organized Sr. Compliance Specialist to join our Compliance team at our St. Louis Park location. Reporting to the Compliance Manager, the Senior Compliance Specialist provides support in the development and administration of the Bank's compliance program and second line of defense. Under minimal supervision, this position will...


  • Minneapolis, United States Bridgewater Bank Full time

    We are seeking a meticulous and organized Sr. Compliance Specialist to join our Compliance team at our St. Louis Park location. Reporting to the Compliance Manager, the Senior Compliance Specialist provides support in the development and administration of the Bank's compliance program and second line of defense. Under minimal supervision, this position will...


  • Minneapolis, United States Best Buy Co. , Inc. Full time

    Senior Strategic Sourcing Specialist, IT Services As the Senior Strategic Sourcing Specialist with IT Services, you will be responsible for sourcing, negotiation, and contracting for an established portfolio of products and services. Youll create va IT, Sourcing, Specialist, Strategic, Senior, Operations, Retail


  • Minneapolis, United States Kerecis LLC Full time

    Job Type Full-time Description Summary The Director of Clinical Affairs is responsible for all clinical aspects of medical device development projects at all stages of the product life cycle, for clinical affairs activities, and for special projects. This full-time role reports to the Senior Vice President of Regulatory Affairs and Quality Assurance and is...