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Regulatory Affairs Manager at Nobel Biocare - ApplyBlast

Regulatory Affairs Manager

Nobel Biocare

4 days ago

3.2 on Glassdoor

Kloten, Zurich, Switzerland

Onsite

Full Time

Manager

0 applicants

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About this role

The Regulatory Affairs Manager oversees regulatory deliverables for prosthetic and digital devices across the EU, US, and Canada, ensuring compliance throughout the product lifecycle. The role involves developing regulatory strategies, managing submissions, and supporting quality audits while integrating AI and automation to enhance operational efficiency. Collaboration with cross-functional teams ensures adherence to global labeling, software, and cybersecurity requirements.

Responsibilities

Manage regulatory aspects of developing new prosthetic and digital devices
Ensure regulatory compliance throughout product lifecycle including post-market surveillance
Identify and implement AI and automation opportunities within Regulatory Affairs