What are the responsibilities and job description for the Regulatory Affairs Specialist position at Laborie?
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, the 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. This individual performs regulatory submission/approval activities for specific complex Laborie Medical products.
About the Role:
- Define worldwide regulatory requirements necessary for regulatory approval of assigned products. Participate on cross functional teams as regulatory lead.
- Complete worldwide regulatory assessments and strategies as required to support assigned projects and prepare technical documentation compliant to MDD and EU MDR.
- Author submissions, research requirements, set priorities and maintain project scheduled.
- Maintain all regulatory documentation to ensure availability for external audits and preparation of submission packages.
- Review protocols and reports for scientific validity and compliance to regulatory standards. Review includes using scientific judgement to guide cross functional teams.
- Provide guidance and oversight to team members related to regulatory compliance.
Minimum Qualifications:
- Bachelor's degree in science, Engineering or other relevant discipline.
- 1-3 years' experience in Regulatory Affairs in medical device industry with international registrations experience
- FDA, EU, Health Canada, and international registration experience.
- Working knowledge with quality systems regulations and guidelines.
- Through understanding of international submission requirements including how to comply with standards and regulations.
Preferred Qualifications:
- BS or MS degree in Science, Engineering or other relevant discipline
- FDA, EU, Health Canada, TGA, PMDA, and international market submission experience.
- Demonstrated ability in project management skills in order to support, plan, conduct and implement product assessments and robust submissions.
- 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
- Awarded 2024 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.
