Regulatory Affairs and Compliance Manager
Burlington, MA (Hybrid)
About LightForce Orthodontics
At LightForce Orthodontics, we use advanced manufacturing technologies and proprietary CAD software to create the world’s best orthodontic treatment experience. We create 100% patient-matched orthodontic ceramic brackets designed from digital impressions with the goal of reducing treatment duration for patients and chair-time for clinicians as well as deliver better treatment outcomes.
We hire committed, self-motivated individuals and give them the freedom and flexibility to do great work. Working at LightForce Orthodontics provides the opportunity to build a fantastic tech company while advancing the orthodontic profession in a way that produces positive health benefits for patients.
LightForce Orthodontics is seeking a talented, motivated, independent regulatory affairs manager to join our journey of transforming the orthodontics industry and help patients across the world enjoy their smile.
The Regulatory Affairs and Compliance Manager will serve an important role in developing key regulatory strategies and executing submissions for new products and markets, timely assessment and reporting on changes for products, and collaborating with Quality and Operations on compliance issues related to ongoing manufacturing activities. You will participate in all product regulatory activities, including quality compliance, and help ensure LightForce Orthodontics provides high quality, safe and effective medical devices. You will ensure regulatory compliance, including with US and global transparency reporting requirements, and will interact with multiple groups both inside and outside the company.
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 Orthodontics 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.
Required & Desired Skills
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 Orthodontics 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 Orthodontics 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.