Laborie Medical Technologies Corp
Senior Regulatory Affairs Specialist
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 our Quality team, the
Senior Regulatory Affairs Specialist
will provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and preparation of submissions. The
Senior Regulatory Affairs Specialist
will perform regulatory submission/approval activities for Laborie products and will represent Laborie with regulatory bodies during external audits as a subject matter expert. The position must ensure compliance with required regulations and established corporate standards and is responsible for ensuring that product approvals are properly maintained, and product re-registrations are properly managed.About the Role:
Preparing documentation for global regulatory submissions and registrations, including 510(k) submissions to the US FDAAuthoring submissions, researching requirements, setting priorities and maintaining project schedulesPreparing technical documentation compliant to MDD and EU MDRDefining worldwide regulatory requirements necessary for regulatory approval of productsAct as a Subject Matter Expert (SME) to support internal and external auditsMaintaining regulatory documentation to ensure availability for external audits and preparation of submission packagesProvide guidance and oversight to team members related to regulatory compliance and participate on cross-functional teams as regulatory leadMinimum Qualifications:
Minimum 8 years' experience in Regulatory Affairs in the medical device industry with a Bachelor's degree in Science, Engineering or other relevant disciplineFDA, EU, Health Canada, and international registrations experienceWorking knowledge of medical devices, procedures and terminology along with quality system regulations and guidelinesAbility to develop clear, concise and timely oral and written reports and communicate across all levels of the organizationWhy 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 LevelLaborie 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.
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As a key member of our Quality team, the
Senior Regulatory Affairs Specialist
will provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and preparation of submissions. The
Senior Regulatory Affairs Specialist
will perform regulatory submission/approval activities for Laborie products and will represent Laborie with regulatory bodies during external audits as a subject matter expert. The position must ensure compliance with required regulations and established corporate standards and is responsible for ensuring that product approvals are properly maintained, and product re-registrations are properly managed.About the Role:
Preparing documentation for global regulatory submissions and registrations, including 510(k) submissions to the US FDAAuthoring submissions, researching requirements, setting priorities and maintaining project schedulesPreparing technical documentation compliant to MDD and EU MDRDefining worldwide regulatory requirements necessary for regulatory approval of productsAct as a Subject Matter Expert (SME) to support internal and external auditsMaintaining regulatory documentation to ensure availability for external audits and preparation of submission packagesProvide guidance and oversight to team members related to regulatory compliance and participate on cross-functional teams as regulatory leadMinimum Qualifications:
Minimum 8 years' experience in Regulatory Affairs in the medical device industry with a Bachelor's degree in Science, Engineering or other relevant disciplineFDA, EU, Health Canada, and international registrations experienceWorking knowledge of medical devices, procedures and terminology along with quality system regulations and guidelinesAbility to develop clear, concise and timely oral and written reports and communicate across all levels of the organizationWhy 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 LevelLaborie 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.
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