We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it 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 in the Portsmouth, NH office. The Senior Regulatory Affairs Specialist provides 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 performs regulatory submission/approval activities for Laborie Medical products and will represent Laborie Medical 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.
How you contribute:Preparing documentation for international regulatory registrationsPreparing technical documentation compliant to MDD and EU MDRDefining worldwide regulatory requirements necessary for regulatory approval of productsParticipating on cross-functional teams as regulatory leadMaintaining regulatory documentation to ensure availability for external audits and preparation of submission packagesAuthoring submissions, researching requirements, setting priorities, and maintaining project schedulesProviding guidance and oversight to team members related to regulatory complianceReviewing marketing literature for compliance to applicable regulationsExecuting on additional responsibilities as defined by managementAct as a Subject Matter Expert (SME) to support internal and external auditsMinimum Qualifications:Bachelor's Degree in Science, Engineering, or other relevant disciplineMinimum 8 years' experience in Regulatory Affairs in the medical device industryFDA, EU, Health Canada, and international registrations experienceWorking knowledge with quality system regulations and guidelinesAbility to develop clear, concise, and timely oral and written reportsGreat communication skills with all levels of personnelHigh level of organization and planning skillsWorking knowledge of medical devices, procedures, and terminologyDrug-combination experience a plusWhy 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 EventsLaborie 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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