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.

IND123 Target Market

Salary Range: $85,700 - $128,500

Pay

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs.

Schedule

The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.

Benefits

The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

Operating Company

Nobel Biocare

EEO Information

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.