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Senior Regulatory Affairs Specialist - Portsmouth, United States - Laborie Medical Technologies Corp
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 ofAspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
Who We're Looking For:
Laborie Medical Technologies is currently searching for a
Senior Regulatory Affairs Specialist
to join our team in the
Portsmouth, NH
office.
The Senior Regulatory Affairs Specialist provides 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 performs regulatory submission/approval activities for Laborie Medical products and will represent Laborie Medical 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.
How you contribute:
Preparing documentation for international regulatory registrations
Preparing technical documentation compliant to MDD and EU MDR
Defining worldwide regulatory requirements necessary for regulatory approval of products
Participating on cross functional teams as regulatory lead
Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages
Authoring submissions, researching requirements, setting priorities and maintaining project schedules
Providing guidance and oversight to team members related to regulatory compliance
Reviewing marketing literature for compliance to applicable regulations
Executing on additional responsibilities as defined by management
Act as a Subject Matter Expert (SME) to support internal and external audits
Minimum Qualifications:
Bachelor's Degree in Science, Engineering, or other relevant discipline
Minimum 8 years' experience in Regulatory Affairs in the medical device industry
FDA, EU, Health Canada, and international registrations experience
Working knowledge with quality system regulations and guidelines
Ability to develop clear, concise, and timely oral and written reports
Great communication skills with all levels of personnel
High level of organization and planning skills
Working knowledge of medical devices, procedures, and terminology
Drug-combination experience a plus
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 timeMedical, 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.
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