Manager – Quality & Regulatory Affairs

Envista Holdings Corporation

. Develop and lead global regulatory strategies to secure and maintain approvals for Versah’s medical device portfolio, with primary ownership of emerging markets .

Posted 9/17/2026full-timeMahwah • New Jersey • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and leading regulatory strategies for medical devices, ensuring compliance with global regulations and quality systems. Proven ability to manage regulatory filings, engage with health authorities, and drive continuous improvement in quality management processes.

Highest-signal resume keywords

Medical Device Regulatory AffairsRegulatory Strategy DevelopmentQuality Management Systems (QMS)21 CFR 820 ComplianceISO 13485 Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory FilingsRegulatory ComplianceProduct Lifecycle ManagementRegulatory AssessmentsImport/Export ComplianceUDI ComplianceCAPA ManagementNonconformance ManagementDocument ControlQuality Records Management

Soft Skills

Critical ThinkingProblem-SolvingDecision-MakingWritten CommunicationVerbal Communication

Certifications & Qualifications

RAPS Certification

Industry Keywords

Medical Device RegulationsQuality SystemsMDDEU MDRQMSRGlobal Regulatory AuthoritiesHealth AuthoritiesSupplier QualificationThird-Party AuditsMarket Expansion

About the role

Key responsibilities & impact

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 product, project, and business requirements across the full product lifecycle
Prepare, submit, and maintain international regulatory filings
Serve as primary contact for health authorities, including negotiation and timely resolution of regulatory questions
Provide regulatory guidance to R&D, Engineering, Quality, Operations, Marketing, and Sales
Ensure alignment with Envista and Nobel Biocare regulatory and quality frameworks
Drive maintenance and continuous improvement of the Versah Quality Management System
Support and participate in external, third-party, and regulatory audits and inspections
Support supplier qualification, incoming inspection/material review, nonconformance management, complaint investigations, CAPA, product traceability, quality records, and document control
Oversee import/export regulatory compliance and country-specific product distribution requirements
Manage and maintain global UDI compliance
Conduct regulatory assessments for business planning, market expansion, and product lifecycle decisions
Monitor, interpret, and communicate changes in global medical device regulations

Requirements

What you’ll need

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, including 21 CFR 820, QMSR, ISO 13485, MDD, and EU MDR
Demonstrated experience leading regulatory strategies and interacting with global regulatory authorities
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
RAPS certification or formal regulatory training are preferred

Benefits

Comp & perks

Annual performance bonus may be included
Medical, dental, and vision benefits
401(k) match
Other applicable compensation plans may be included