Career Center
Durham, North Carolina
Durham, North Carolina
Salinas, California
Alexandria, Virginia
Alexandria, Virginia
Posted: 24-May-23
Location: Burlington, Massachusetts
Type: Full Time
Categories:
Internal Number: 12
Position
Regulatory Affairs and Compliance Manager
Location
Onsite
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.
Job Description
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.
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 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.
Responsibilities
- Design and implement regulatory strategies for all products in existing markets and for market expansion
- Monitor and assess global regulation changes and provide leadership 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 more junior 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
- 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
- Lead the interactions between internal and external participants of regulatory interactions, including internal training and regulatory awareness creation
- Review labeling, promotional materials and training materials for regulatory compliance
- Own 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 direct reports
Required & Desired Skills
- Knowledge of ISO 13485 and MDSAP required
- Previous audit experience required
- Previous experience in multi-country medical device licensing and maintenance is required
- Experience in the MDR process is a plus
- Bachelor’s degree or equivalent with 5+ years in regulatory, compliance, audit and/or other related experience
- Medical device or pharmaceutical experience required
- 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
- Fluent in English (verbal and written)
- Effective written and oral communication, and technical writing skills
- Effective research and analytical skills
- Ability to interpret regulations, standards and guidance documents and implement requirements
- Ability to work independently with minimal supervision
- Supervisory experience required
- 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
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 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.
Required & Desired Skills
- Knowledge of ISO 13485 and MDSAP required
- Previous audit experience required
- Previous experience in multi-country medical device licensing and maintenance is required
- Experience in the MDR process is a plus
- Bachelor’s degree or equivalent with 5+ years in regulatory, compliance, audit and/or other related experience
- Medical device or pharmaceutical experience required
- 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
- Fluent in English (verbal and written)
- Effective written and oral communication, and technical writing skills
- Effective research and analytical skills
- Ability to interpret regulations, standards and guidance documents and implement requirements
- Ability to work independently with minimal supervision
- Supervisory experience required
- 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
