LightForce Ortho

Position

Regulatory Affairs Specialist

Location

Costa Rica

This position is a remote position but requires the ability to travel periodically to our HQ and other facilities for auditing and other regulatory activities.

    About LightForce

    LightForce is a 3D printing technology company focused on the orthodontic space. Our digital platform empowers orthodontists with fully customized, 3D-printed tooth-moving tools. In 2019, we launched our first product - the world’s only, fully customized 3D printed bracket system and digital treatment software. We are proud to be one of the fastest growing companies in the industry. Learn more at: www.lf.co

    Description

    LightForce is seeking a talented, motivated, independent regulatory affairs specialist to join our journey of transforming the orthodontics industry and help patients across the world enjoy their smile.

    In your role as regulatory affairs (RA) specialist you will participate in all regulatory activities and help ensure LightForce provides high quality, safe and effective medical devices. You will ensure regulatory compliance and will interact with multiple groups within & outside the company.

    We hire committed, self-motivated individuals and give them the freedom and flexibility to do great work. Working at LightForce provides the opportunity to build a fantastic tech company while advancing the orthodontic profession in a way that produces positive health benefits for patients.

    About You

    We believe that great people build great companies. We are looking for individuals who are intrinsically motivated to do good work, love to collaborate with other team members across the company and always keep the customer and patient top of mind.

    LightForce is growing quickly and has a fast paced environment. You will need to adjust, help develop our processes and overall feel comfortable with change and uncertainty.

    Essential Responsibilities

    • Develop strategies and submissions for regulated, medical device products to gain approvals for commercial distribution
    • Assist in the preparation of responses to the regulatory bodies review letters and requests for additional information
    • Interface with FDA and other International Regulatory Agency personnel
    • Support international product registrations
    • Prepare and maintain product technical files
    • Prepare and maintain various documentation required by the FDA and other regulatory bodies
    • Review labeling material
    • Participate as an auditor in internal audit activities
    • Help organize customer interactions including feedback and complaints
    • Participate and coordinate management reviews, quality planning activities, training needs analysis and other similar yearly activities.
    • Help updating and maintaining our regulatory documentation
    • Track ISO publications and help LightForce remain state-of-the art regarding standards

    Required Qualifications

    • Bachelor’s Degree in medical or science related field
    • Fluent in English (verbal and written)
    • Effective written and oral communication, technical writing and editing skills
    • Effective research and analytical skills
    • Ability to work independently with minimal supervision
    • Ability to manage several projects simultaneously
    • Ability to work with various technical tools (GitHub, JIRA, Word, etc.)
    • Ability to work with reporting tools

    Physical Demands

    While performing the essential functions of this job, an individual is regularly required to sit or stand, see, use hands, listen, and speak.

    We are committed to building a diverse and inclusive company and we are most interested in finding the BEST candidate for the job. We would strongly encourage you to apply, even if you don't believe you meet every one of the preferred qualifications described.

    LightForce has a Mandatory COVID-19 Vaccination Policy, which requires team members to be fully vaccinated against COVID-19 or be approved for a medical or religious exemption with accommodations in order to partake in certain activities in the United States.

    LightForce is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state, or local law.