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Regulatory Affairs and Compliance Manager, Part-time

Hybrid, 1-2 days per week in Burlington, Massachusetts

About LightForce Orthodontics

LightForce Orthodontics is a technology company focused on a new era of personalized orthodontics that launched the world's only fully customized digital bracket system in 2019. Our ecosystem combines precisely manufactured 3D-printed braces and digital treatment planning software empowering orthodontists to deliver remarkable results. We are proud to be one of the fastest growing companies in the industry. Learn more at www.lf.co.

Description

LightForce Orthodontics is seeking a talented Regulatory Affairs and Compliance Manager to join our journey of transforming the orthodontics industry. The ideal candidate will be as passionate about protecting our customers as they are about ensuring that our business and products comply with all relevant regulations.

The Regulatory Affairs and Compliance Manager will work independently, as well as cross-functionally, to develop key regulatory strategies and execute submissions for new products and markets. They will also timely assess and report on changes to products, and collaborate 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 lead LightForce’s regulatory compliance efforts, including with US and global transparency reporting requirements, and will interact with multiple groups both inside and outside the company.

*This is a part time position with a flexible schedule. 

Essential Duties and Responsibilities

  • Design and implement regulatory strategies, and collaborate cross-functionally to execute on those strategies, for all products in existing markets and for market expansion
  • Monitor and assess global regulation changes and provide leadership/guidance to the organization for implementation
  • Plan, analyze and prepare regulatory submissions for FDA, Health Canada, the Therapeutic Goods Administration and other international agencies, and provide guidance to collaborating team members for assistance with submissions
  • Ensure that quality system requirements for medical devices are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304 and other regulations and guidelines as applicable
  • Lead the interactions between internal and external participants of regulatory interactions, including internal training
  • Review labeling, promotional materials and training materials for regulatory compliance
  • Lead internal audits and management reviews
  • Assist with data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authorities
  • Maintain understanding of disclosure laws, regulations and applicable industry codes
  • Mentor, develop, and coach cross-functional collaborators 

Education and Experience 

  • Bachelor’s degree or higher with 5+ years in regulatory, compliance or audit
  • Medical device or pharmaceutical Industry
  • Filing paperwork for FDA
  • Multi-country presence with a medical device 
  • Experience with researching, creating and executing on regulatory strategies for lean companies and products, including Laboratory Developed Tests, 510(k) clearances, Direct to Consumer and other considerations

Required Qualifications

  • Knowledge of ISO 13485 and MDSAP
  • Fluent in English (verbal and written)
  • Effective written and oral communication, and technical writing skills
  • Effective research and analytical skills
  • Able to interpret regulations, standards and guidance documents and implement requirements
  • Ability to work independently with minimal supervision
  • Ability to manage several projects simultaneously
  • Ability to work with various technical tools (GitHub, JIRA, Confluence, etc.)
  • Ability to work with reporting tools
  • Ability to use technical systems for managing regulatory documents and records

Preferred Qualifications

  • Experience in the MDR process is a plus
  • Knowledge of and experience with laws, regulations, and industry guidance that affect the medical device industry including global aggregate spend and reporting/transparency laws, fraud and abuse and anti-kickback statutes, the Sunshine Act, and AdvaMed Code of Ethics is a plus
  • Experience with US and global transparency reporting is a plus

Physical Demands

  • Requires the ability to use hands, and reach with hands and arms
  • Requires the ability to see, listen, and speak

Work Environment

  • Work is generally performed in an open office, sedentary position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

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