Senior Regulatory Affairs Specialist – Medical Devices

About the role

Enovis is seeking an experienced Senior Regulatory Affairs Specialist to lead regulatory strategy and submission activities for orthopedic medical devices, including hardware and software as a medical device (SaMD) solutions. The role will support product launches and the integration of machine‑learning and artificial‑intelligence technologies.

Key responsibilities

• Develop and execute global regulatory strategies for new and modified products.
• Lead pre‑submission meetings with FDA, Notified Bodies and the TGA.
• Manage regulatory activities across the United States, European Union and Australian markets.
• Ensure compliance with TGA regulations, EU MDR, ISO 13485, ISO 14971 and 21 CFR 820.
• Coordinate post‑market surveillance and regulatory impact assessments.
• Provide regulatory subject‑matter expertise to cross‑functional teams.

Required profile

• Proven experience in medical‑device regulatory affairs, both hardware and SaMD.
• Strong knowledge of US, EU and Australian regulatory frameworks.
• Ability to work collaboratively with clinical, engineering and quality teams.
• Experience supporting AI/ML‑enabled medical technologies.

Required skills

• Regulatory strategy development
• Regulatory submission management
• Knowledge of TGA, EU MDR, ISO 13485, ISO 14971, 21 CFR 820
• Post‑market surveillance
• Regulatory impact assessment
• Medical device hardware
• Software as a Medical Device (SaMD)
• Machine learning and artificial intelligence concepts

What we offer

• Opportunity to shape regulatory pathways for innovative orthopedic technologies.
• Collaborative, science‑driven environment.
• Access to global resources and expertise.