Global Medical Device Regulatory Lead

Nobel Biocare

Mahwah (NJ)

On-site

USD 120,000 - 160,000

Full time

9 days ago

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Job summary

Nobel Biocare (Versah, LLC) seeks an experienced Regulatory Affairs professional to advance global regulatory compliance and enhance the Quality Management System. The role emphasizes developing regulatory strategies, working with authorities, and building audit-ready processes.

You will partner with R&D, Engineering, Quality, Operations, Marketing, and Sales to translate regulations into product requirements, maintain filings, and ensure global compliance including UDI and import/export

Qualifications

Bachelor’s degree in scientific or technical discipline.
5+ years of regulatory affairs experience in medical devices.
Knowledge of 21 CFR 820, ISO 13485, EU MDR.
RAPS certification or equivalent regulatory training preferred.
Strong communication and cross-functional leadership.
Ability to work independently and manage multiple priorities.

Responsibilities

Develop and lead global regulatory strategies for the medical device portfolio.
Prepare, submit, and maintain international regulatory filings; be primary contact for authorities.
Guide cross-functional teams on regulatory requirements across the product lifecycle.
Ensure alignment with Envista and Nobel Biocare frameworks; maintain the QMS.
Support audits, supplier qualification, CAPA, and product traceability.
Oversee import/export compliance and global UDI.
Monitor regulatory changes to inform planning and lifecycle decisions.