Regulatory Specialist

Medit is a global leader in 3D scanning and digital workflow solutions, valued at over $2.2 billion and operating in more than 100 countries. We are hiring a Regulatory Affairs & Quality Assurance (RAQA) Specialist to lead regulatory and quality compliance across the U.S., Canada, and LATAM. This hybrid role, based in Newport Beach, CA, will serve as the primary RAQA contact for North America and LATAM, working directly with global counterparts in Korea. The ideal candidate has proven experience with FDA 510(k), Health Canada licensing, and LATAM submissions, as well as strong working knowledge of ISO 13485, ISO 14971, and software-based medical devices.

Key Responsibilities

Regulatory Affairs

• Lead all regulatory activities for U.S., Canada, and LATAM markets.
• Prepare and manage regulatory submissions, including 510(k), MDEL, and LATAM filings.
• Serve as primary liaison with FDA, Health Canada, and LATAM authorities.
• Monitor regional regulatory changes and provide internal guidance on impact and strategy.

Quality Assurance

• Maintain and improve Medit’s Quality Management System (QMS) in accordance with ISO 13485 and applicable regional regulations.
• Manage internal audits and ensure readiness for external inspections (e.g., FDA, Health Canada).
• Oversee quality compliance for importation, warehousing, and distribution in coordination with 3PL partners.
• Handle complaint investigations and manage Medical Device Reporting (MDR) per 21 CFR 803, 806, and 810.

Cross-functional Support

• Partner with R&D, Clinical, and Product teams to ensure regulatory compliance in product development and launch.
• Support post-market surveillance and field safety corrective actions as needed.
• Provide input on labeling, UDI, and documentation reviews from a regulatory standpoint.

Training & Communication

• Deliver internal training on regulatory/quality requirements and updates.
• Act as a subject matter expert for U.S., Canada, and LATAM compliance, advising executive leadership as needed.

Qualifications

• Bachelor’s degree in regulatory affairs, life sciences, biomedical engineering, or a related field (Master’s preferred).
• 6 years of regulatory and quality experience in the medical device industry.
• Direct experience preparing and submitting FDA 510(k)s and Health Canada applications; LATAM regulatory experience required.
• Strong knowledge of ISO 13485, ISO 14971, and global QMS requirements.
• Experience with software-driven or digital medical devices strongly preferred.
• Familiarity with post-market requirements and regulatory reporting (MDR/Vigilance).
• Excellent documentation, project management, and cross-functional collaboration skills.
• Fluent in English; Spanish or Portuguese a plus.

Preferred Experience

• Background working in global or matrixed organizations.
• Experience with regulatory and QMS software platforms.
• Strong analytical, audit, and problem-solving capabilities.
• Ability to work independently and navigate time zone differences with global teams.