What are the responsibilities and job description for the Senior 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
Laborie Medical Technologies is currently searching for a Senior Regulatory Affairs Specialist to join our team. This role is responsible for leading and supporting global regulatory submissions, including those for the United States, Canada, Europe, and other international markets. The ideal candidate will have direct experience with U.S. Class III PMA submissions, and combination device experience is highly desirable. The candidate will perform regulatory submission and approval activities for specific Laborie Medical products and ensure compliance with required regulations and established corporate standards.
How You Contribute
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.
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. This role is responsible for leading and supporting global regulatory submissions, including those for the United States, Canada, Europe, and other international markets. The ideal candidate will have direct experience with U.S. Class III PMA submissions, and combination device experience is highly desirable. The candidate will perform regulatory submission and approval activities for specific Laborie Medical products and ensure compliance with required regulations and established corporate standards.
How You Contribute
- Preparing and managing documentation for global regulatory submissions, registrations, and renewals.
- Defining worldwide regulatory requirements necessary for regulatory approval of assigned products.
- Developing and executing product submission strategies to support product approvals and lifecycle management.
- Collaborating cross-functionally to ensure regulatory compliance throughout product development and commercialization.
- Participating in external audits and ensuring regulatory documentation is properly maintained and readily available for audit activities.
- Maintaining a thorough knowledge of current regulatory requirements.
- Executing on additional responsibilities as defined by management.
- Bachelor’s Degree in Science, Engineering, or other relevant discipline and 8 years’ experience in Regulatory Affairs in the medical device industry.
- Proven experience with U.S. Class III PMA submissions, Investigational Device Exemption (IDE) submissions, FDA pre-submissions, and EU MDR technical documentation submissions.
- Experience with combination devices is a strong plus.
- Solid understanding and 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.
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
