Regulatory Affairs Specialist I
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 on 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.
About the Role
The Regulatory Affairs Specialist will support global product registration, approval, and lifecycle maintenance activities across key markets, including the United States, Canada, Europe, and other international regions. This role is responsible for ensuring that regulatory approvals are obtained, maintained, and renewed in accordance with applicable regulatory requirements and internal standards. The individual will contribute to regulatory strategy and execution for assigned product lines, including:
- Preparing and submitting regulatory submissions
- Managing product registrations and renewals
- Ensuring ongoing compliance with global regulatory requirements
- Working cross-functionally to support product changes and maintain regulatory documentation
- Ensuring alignment with established corporate procedures and quality standards
Key responsibilities include:
- Preparing and submitting documentation necessary for regulatory approval of assigned products
- Defining worldwide regulatory requirements necessary for regulatory approval of assigned products, and advising cross-functional teams on regulatory strategies
- 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
Requirements
- Bachelor’s degree in Science, Engineering, or other relevant discipline
- 1-3 years' experience in Regulatory Affairs in the medical device industry
- 1-3 years' experience in international registrations
- 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
Benefits
- 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 2025 Cigna Healthy Workforce Designation Gold Level.
About Us
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.