Regulatory Operations Specialist

Posted 20 Days Ago
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Portsmouth, NH, USA
In-Office
Junior
Healthtech • Biotech
The Role
Manages regulatory operations for medical products, including SAP data maintenance, submission documentation, regulatory reporting, notarization and legalization processes, license renewals, product re-registrations, and distributor renewal tracking. Collaborates with Supply Chain, Quality, Sales, Customer Care, and Manufacturing to maintain product approvals and regulatory compliance.
Summary Generated by Built In

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 apostille; 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 2025 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.

 

Skills Required

  • 2+ years of industry experience
  • Associate degree in Science, Engineering, or another relevant discipline
  • Ability to develop clear, concise, and timely oral and written reports
  • Ability to communicate tactfully with all levels of personnel
  • Proficiency with Microsoft Office and Adobe publishing
  • Strong analytical and problem-solving skills
  • Bachelor's degree in Science, Engineering, or another relevant discipline
  • Strong planning and organizational skills
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The Company
HQ: Portsmouth
612 Employees
Year Founded: 1967

What We Do

Laborie develops innovative medical technologies – including diagnostic equipment and consumable supplies – in the Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology fields. We take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. LABORIE is comprised of a variety of powerful brands – cultivated over more than 50 years of providing innovative products and services to our customers. Our story is one of continuous profitable growth, driven both organically and inorganically through mergers and acquisitions. We are privately owned by Patricia Industries and a part of the Investor AB network. Our owners take a long-term investment approach and create value for people and society by building strong and sustainable businesses. We know the work we do at LABORIE matters – we’re making a positive impact in the lives of patients across the globe. This is what fuels our motivation each day.

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