Principal Regulatory Affairs Specialist
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:
The Principal Regulatory Affairs Specialist is an expert-level team member responsible for leading regulatory activities to support global product approvals and lifecycle management for Laborie Medical products. This role involves hands-on development of regulatory strategies, preparation of submissions, and direct interaction with regulatory bodies. The specialist ensures compliance with global regulations and corporate standards, maintains product approvals, and manages re-registration processes.
How you contribute:
- Prepare and manage documentation for global regulatory submissions, registrations, and renewals.
- Define worldwide regulatory requirements for assigned products.
- Develop and execute submission strategies to support product approvals and lifecycle management.
- Collaborate cross-functionally to ensure regulatory compliance throughout product development and commercialization.
- Participate in external audits and ensure regulatory documentation is maintained and audit-ready.
- Support projects involving novel technologies with complex or undefined regulatory pathways.
- Serve as a core team member for new-to-market technologies (e.g., mobile medical apps, remote monitoring programs).
- Develop regulatory strategies for complex technologies and cross-linked programs.
- Lead preparation and management of complex submissions (e.g., original PMA, Panel Track 180-day, Traditional 510(k)).
- Lead regulatory task forces for special projects (e.g., EU UDI, cybersecurity, process improvement initiatives).
- Represent the company in regulatory trade and advocacy groups.
- Mentor and guide junior regulatory team members on regulatory projects and topics.
- Maintain up-to-date knowledge of global regulatory requirements.
- Perform additional responsibilities as assigned by management.
Qualifications:
- Bachelor’s degree in Science, Engineering, or a related discipline with 16+ years of regulatory affairs experience in the medical device industry (10+ years with a Master’s degree).
- Proven experience with U.S. Class III PMA submissions, Investigational Device Exemption (IDE) submissions, FDA pre-submissions, and EU MDR technical documentation.
- Experience with complex medical devices and/or combination devices.
- Strong understanding of quality system regulations and global regulatory guidelines.
- Excellent communication skills across all organizational levels.
- High level of organizational and planning capability.
- Solid 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
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.