Regulatory Operations Specialist

Laborie; Portsmouth (NH); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision

Health Savings Account

401k with Company Match

Parental Leave

Wellness Programs

Job summary

Laborie in Portsmouth, NH, is seeking a Regulatory Operations Specialist to ensure product approvals are maintained and re-registrations managed. You’ll collaborate with Supply Chain, Quality, Sales, Customer Care and Manufacturing to keep filings up to date and reports accurate.

You’ll create SAP data, publish submission docs, renew licenses, and advise on renewal schedules, contributing to our mission to advance healthcare technology that improves lives.

Qualifications

• 2+ years of industry experience.
• Proficiency with MS Office and Adobe publishing.
• Strong analytical skills and the ability to solve problems through analytical reasoning.

Responsibilities

• Create and maintain data for import/export, inclusions and manufacturing implementations in SAP.
• Publish submission documentation, maintain submission logs, and generate reports as necessary.
• Process documents for notarization, legalization and a postille; maintain State and Regulatory Body License renewals as required.
• Advise Regulatory staff of registration renewals and maintain distributor renewal log.

Skills

Analytical skills

MS Office

Adobe publishing

Report writing

Communication

Education

AS degree in Science or Engineering

BS degree in Science or Engineering (preferred)

Tools

SAP

Job description

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:

As a key member of the Regulatory team, the Regulatory Operations Specialist will interact with Supply Chain, Quality, Sales, Customer Care and Manufacturing, ensuring that product approvals are properly maintained, and product re-registrations are properly managed.

About the Role:

• Create and maintain data for import / export, inclusions as well as manufacturing implementations in SAP.
• Publish submission documentation, maintain submission logs, and generate reports as necessary.
• Process documents for notarization, legalization and a postille; maintain State and Regulatory Body License renewals as required.
• Advise Regulatory staff of registration renewals and maintain distributor renewal log.

Minimum Qualifications:

• 2+ years of industry experience.
• AS degree in Science, Engineering, or other relevant discipline.
• Must have the ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.
• Proficiency with MS Office and Adobe publishing.
• Strong analytical skills and the ability to solve problems through analytical reasoning.

Preferred Qualifications:

• BS degree in Science, Engineering, or other relevant discipline.
• Strong planning and organizational skills.

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
• Awarded 202 5 Cigna Healthy Workforce Designation Gold Level

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.