Laborie Medical Technologies Corp
Regulatory Affairs Specialist I
Laborie Medical Technologies Corp, Minnetonka, Minnesota, United States, 55345
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:
As a key member of the Regulatory team based out of Portsmouth, NH or Minnetonka, MN the Regulatory Affairs Specialist will be responsible for supporting global product marketing approvals/clearances and renewals (United States, Canada, Europe, international markets, etc.) This individual would make sure product approvals are properly maintained, and product re-registrations are properly managed. Additionally, this role performs regulatory submission/approval activities and maintain compliance with required regulations and established corporate standards.
About the Role:
Preparing and submitting documentation necessary for regulatory approval of assigned productsDefining worldwide regulatory requirements necessary for regulatory approval of assigned products, and advising cross-functional teams on regulatory strategiesExecuting product submission strategies as directedMaintaining all regulatory documentation to ensure availability for external audits and preparation of submission packagesMaintaining a thorough knowledge of current regulatory requirementsExecuting on additional responsibilities as defined by managementMinimum Qualifications:
Bachelor's Degree in Science, Engineering, or other relevant discipline1-3 years' experience in Regulatory Affairs in the medical device industry1-3 years' experience in international registrationsWorking knowledge of quality system regulations and guidelinesGreat communication skills with all levels of personnelHigh level of organization and planning skillsWorking knowledge of medical devices, procedures, and terminologyWhy 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 timeMedical, Dental, Vision and Flexible Spending AccountHealth Savings Account with Company Funded Contributions401k Retirement Plan with Company MatchParental Leave and Adoption ServicesHealth and Wellness Programs and EventsAwarded 2023 Cigna Healthy Workforce Designation Gold Level
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.
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:
As a key member of the Regulatory team based out of Portsmouth, NH or Minnetonka, MN the Regulatory Affairs Specialist will be responsible for supporting global product marketing approvals/clearances and renewals (United States, Canada, Europe, international markets, etc.) This individual would make sure product approvals are properly maintained, and product re-registrations are properly managed. Additionally, this role performs regulatory submission/approval activities and maintain compliance with required regulations and established corporate standards.
About the Role:
Preparing and submitting documentation necessary for regulatory approval of assigned productsDefining worldwide regulatory requirements necessary for regulatory approval of assigned products, and advising cross-functional teams on regulatory strategiesExecuting product submission strategies as directedMaintaining all regulatory documentation to ensure availability for external audits and preparation of submission packagesMaintaining a thorough knowledge of current regulatory requirementsExecuting on additional responsibilities as defined by managementMinimum Qualifications:
Bachelor's Degree in Science, Engineering, or other relevant discipline1-3 years' experience in Regulatory Affairs in the medical device industry1-3 years' experience in international registrationsWorking knowledge of quality system regulations and guidelinesGreat communication skills with all levels of personnelHigh level of organization and planning skillsWorking knowledge of medical devices, procedures, and terminologyWhy 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 timeMedical, Dental, Vision and Flexible Spending AccountHealth Savings Account with Company Funded Contributions401k Retirement Plan with Company MatchParental Leave and Adoption ServicesHealth and Wellness Programs and EventsAwarded 2023 Cigna Healthy Workforce Designation Gold Level
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.