Global Regulatory Affairs Lead, Medical Devices

Envista; Mahwah (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health & Wellbeing

Retirement & Financial Benefits

Life & Disability Insurance

Paid Time Off

Job summary

Versah, LLC, now part of the Envista family, seeks a Regulatory Affairs leader to develop global strategies and maintain regulatory approvals for its medical device portfolio. You will collaborate with R&D, Engineering, Quality, Operations, Marketing, and Sales to support product lifecycle activities.

The role emphasizes compliance with 21 CFR 820, ISO 13485, and EU MDR, while guiding audits and regulatory interactions across markets.

Qualifications

• Bachelor’s degree in scientific or technical discipline.
• 5+ years in medical device regulatory affairs with quality systems exposure.
• Strong knowledge of medical device regs and quality systems (e.g., 21 CFR 820, ISO 13485, EU MDR).
• Experience leading regulatory strategies and engaging with global authorities.
• RAPS certification or formal regulatory training preferred.
• Excellent written and verbal communication; able to influence at multiple levels.

Responsibilities

• Develop and lead global regulatory strategies for Versah’s medical device portfolio.
• Interpret regulations and translate into product/project requirements.
• Prepare, submit, and maintain international regulatory filings; liaise with health authorities.
• Provide regulatory guidance to cross-functional partners for new product development and sustaining activities.
• Ensure alignment with Envista/Nobel Biocare frameworks and maintain QMS.
• Support audits, supplier qualification, CAPA, and document control.
• Oversee import/export regulatory compliance and global UDI compliance.
• Monitor changes in global regulations and communicate impact.

Skills

Regulatory strategy

Quality systems

Global communication

Independent work

Cross-functional collaboration

Education

Bachelor's degree in scientific/technical field

Tools

eCTD submissions

Regulatory databases

Job description

Versah, LLC, now part of the Envista family, seeks a Regulatory Affairs leader to develop global strategies and maintain regulatory approvals for its medical device portfolio. You will collaborate with R&D, Engineering, Quality, Operations, Marketing, and Sales to support product lifecycle activities.

The role emphasizes compliance with 21 CFR 820, ISO 13485, and EU MDR, while guiding audits and regulatory interactions across markets.