Manager - Quality & Regulatory Affairs

Duties And Responsibilities

• Develop and lead global regulatory strategies to secure and maintain approvals for Versah’s medical device portfolio, with primary ownership of emerging markets.
• Interpret global and regional regulations and translate them into clear product, project, and business requirements across the full product lifecycle.
• Prepare, submit, and maintain international regulatory filings; serve as the primary contact for health authorities, including negotiation and timely resolution of regulatory questions.
• Provide regulatory guidance to cross-functional partners (R&D, Engineering, Quality, Operations, Marketing, and Sales) to support both new product development and sustaining activities.
• Ensure alignment with Envista and Nobel Biocare regulatory and quality frameworks, and drive maintenance and continuous improvement of the Versah Quality Management System in accordance with applicable regulations and standards.
• Support and participate in external, third-party, and regulatory audits/inspections in collaboration with Regulatory and Quality leadership.
• Support supplier qualification, incoming inspection/material review, and nonconformance management; support complaint investigations and CAPA; and maintain product traceability, quality records, and document control.
• Oversee import/export regulatory compliance and ensure adherence to country-specific requirements for product distribution.
• Manage and maintain global UDI compliance across all applicable markets.
• Conduct regulatory assessments to inform business planning, market expansion, and product lifecycle decisions.
• Monitor, interpret, and communicate changes in global medical device regulations to drive ongoing compliance and organizational awareness.

Qualifications/skills

• Bachelor’s degree in scientific or technical discipline
• 5+ years of experience in medical device regulatory affairs, with exposure to quality systems
• Strong working knowledge of medical device regulations and quality systems (e.g., 21 CFR 820, QMSR, ISO 13485, MDD & EU MDR).
• Demonstrated experience leading regulatory strategies and interacting with global regulatory authorities
• RAPS certification or formal regulatory training are preferred
• Excellent critical thinking, problem-solving, and decision-making skills
• Strong written and verbal communication skills with the ability to influence at multiple organizational levels
• Proven ability to work independently, manage multiple priorities, and lead cross-functional collaboration.