Regulatory Affairs and Compliance Manager - Remote

Overview

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.

In Short

• Design and implement regulatory strategies for existing products and market expansion.
• Monitor global regulation changes and provide leadership for implementation.
• Prepare regulatory submissions for FDA and other agencies.
• Ensure quality system requirements for medical devices are maintained.
• Lead internal and external regulatory interactions.
• Review materials for regulatory compliance.
• Conduct internal audits and management reviews.
• Assist with transparency reports to authorities.
• Mentor and develop cross-functional collaborators.

Requirements

• Bachelor’s degree or higher with 5+ years in regulatory, compliance or audit.
• Experience in the medical device or pharmaceutical industry.
• Knowledge of ISO 13485 and MDSAP.
• Fluent in English (verbal and written).
• Effective communication and technical writing skills.
• Ability to interpret regulations and implement requirements.
• Ability to manage multiple projects simultaneously.
• Experience with technical tools like GitHub, JIRA, and Confluence.

Benefits

• Flexible schedule.
• Opportunity to work in a growing industry.
• Collaborative work environment.
• Professional development opportunities.