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Regulatory Affairs Specialist Ii

4 months ago

Portsmouth, United States Laborie Medical Technologies Corp Full time

**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 **Regulatory Affairs Specialist** to join our team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific Laborie Medical products and ensures compliance with required regulations and established corporate standards.

**How you contribute**:

- Preparing documentation for international regulatory registrations and renewals.
- Defining worldwide regulatory requirements necessary for regulatory approval of assigned products.
- 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.

**Qualifications**:

- Bachelor’s Degree in Science, Engineering, or other relevant discipline.
- 4+ 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.

**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._