Regulatory Affairs Specialist I

About Laborie and the Role

Laborie is dedicated to advancing healthcare by developing technologies that uphold human dignity. We aim to positively influence the patient experience globally through meaningful work and a culture that fosters growth, inclusivity, and collaboration. Employees are encouraged to work together and are recognized based on core values such as Aspire to Greatness, Respect All, Own It, Working Together, and Persist with Passion.

We are currently seeking a Regulatory Affairs Specialist for a hybrid role located in Portsmouth, NH, or Minnetonka, MN. This position involves supporting global product registration, approvals, and lifecycle maintenance for key regions including the U.S., Canada, Europe, and other international markets. The specialist will ensure compliance with regulatory standards and contribute to regulatory strategies for assigned products.

Key Responsibilities

• Prepare and submit documents required for regulatory approval of assigned product lines.
• Identify global regulatory requirements necessary for approvals and counsel cross-functional teams on regulatory plans.
• Implement product submission plans as directed by management.
• Maintain comprehensive regulatory documentation to support external audits and submission preparations.
• Stay informed of current regulatory standards and requirements.
• Carry out additional duties as assigned by management.

Required Qualifications

• Bachelor’s degree in Science, Engineering, or a related field.
• 1 to 3 years of experience in Regulatory Affairs within the medical device sector.
• 1 to 3 years' experience managing international product registrations.
• Practical knowledge of quality system regulations and guidelines applicable to medical devices.
• Strong communication skills across all organizational levels.
• Excellent organizational and planning capabilities.
• Familiarity with medical devices, relevant procedures, and terminology.

Why Join Laborie?

• Paid time off and paid volunteer leave.
• Comprehensive Medical, Dental, Vision coverage and Flexible Spending Account options.
• Health Savings Account with company contributions.
• 401k retirement savings plan with company matching.
• Parental leave and adoption assistance.
• Health and wellness programs and initiatives.
• Recipient of the 2025 Cigna Healthy Workforce Designation at the Gold Level.

Equal Opportunity Statement

Laborie offers equal employment opportunities to all qualified individuals without discrimination on the basis of race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any other protected category. We are committed to providing reasonable accommodations to individuals with disabilities.