Job details

Senior Regulatory Affairs Specialist

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 our Quality team, the Senior Regulatory Affairs Specialist will provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and preparation of submissions. The Senior Regulatory Affairs Specialist will perform regulatory submission/approval activities for Laborie products and will represent Laborie with regulatory bodies during external audits as a subject matter expert. The position must ensure compliance with required regulations and established corporate standards and is responsible for ensuring that product approvals are properly maintained, and product re-registrations are properly managed.

About the Role:

Preparing documentation for global regulatory submissions and registrations, including 510(k) submissions to the US FDA
Authoring submissions, researching requirements, setting priorities and maintaining project schedules
Preparing technical documentation compliant to MDD and EU MDR
Defining worldwide regulatory requirements necessary for regulatory approval of products
Act as a Subject Matter Expert (SME) to support internal and external audits
Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages
Provide guidance and oversight to team members related to regulatory compliance and participate on cross-functional teams as regulatory lead

Minimum Qualifications:

Minimum 8 years' experience in Regulatory Affairs in the medical device industry with a Bachelor's degree in Science, Engineering or other relevant discipline
FDA, EU, Health Canada, and international registrations experience
Working knowledge of medical devices, procedures and terminology along with quality system regulations and guidelines
Ability to develop clear, concise and timely oral and written reports and communicate across all levels of the organization

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 2023 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.

By Laborie Medical Technologies Corp

Founded in 1967, Laborie manufactures and supplies pelvic health and gastrointestinal equipment and consumables for urodynamic testing. Laborie is located in Canada.

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FUNDING

Private

DEPARTMENTS

Quality Assurance

SENIORITY LEVEL REQUIREMENT

Senior

TEAM SIZE

501-1000

LOCATION