Global Regulatory & Quality Manager

Envista Holdings Corporation; Mahwah, Northern (NJ, KY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Versah, LLC, part of the Envista family, is seeking a Manager of Quality & Regulatory Affairs to lead global regulatory strategies for its medical device portfolio. You will own regulatory pathways, interpret global rules, and align with QMS frameworks to enable market access.

You will collaborate with R&D, Engineering, Quality, Operations, and Marketing to develop filings, maintain QMS compliance, and prepare for audits.

Qualifications

• Bachelor’s degree in scientific or technical discipline.
• 5+ years of regulatory affairs experience for medical devices.
• Strong knowledge of medical device regulations (e.g., 21 CFR 820, ISO 13485, EU MDR).

Responsibilities

• Develop and lead global regulatory strategies to secure approvals for Versah’s medical device portfolio.
• Interpret global/regional regulations and translate into product requirements across the lifecycle.
• Prepare, submit, and maintain international regulatory filings; liaise with health authorities.

Skills

Regulatory strategy

Global authorities

Cross-functional leadership

Communication skills

Problem solving

Education

Bachelor's degree (scientific or technical)

Job description

Versah, LLC, part of the Envista family, is seeking a Manager of Quality & Regulatory Affairs to lead global regulatory strategies for its medical device portfolio. You will own regulatory pathways, interpret global rules, and align with QMS frameworks to enable market access.

You will collaborate with R&D, Engineering, Quality, Operations, and Marketing to develop filings, maintain QMS compliance, and prepare for audits.