Senior Regulatory Affairs Specialist

About the role

Enovis is seeking an experienced Senior Regulatory Affairs Specialist to lead regulatory strategy and product submission activities for orthopedic medical devices, including hardware and software as a medical device (SaMD). The role will support global market entry and post‑market compliance across the United States, European Union, and Australia.

Key responsibilities

• Develop and execute global regulatory strategies for new and modified products.
• Lead pre‑submission meetings with FDA, Notified Bodies, and TGA.
• Collaborate with clinical affairs, engineering, and product teams to align regulatory requirements.
• Ensure compliance with TGA regulations, EU MDR, ISO 13485, ISO 14971, and 21 CFR 820.
• Manage post‑market surveillance activities and regulatory impact assessments.
• Provide regulatory subject‑matter expertise for AI/ML‑enabled medical technologies.

Required profile

• Proven experience in medical device regulatory affairs, preferably in orthopedics.
• Strong knowledge of US, EU, and Australian regulatory frameworks.
• Experience with hardware and SaMD products, including AI/ML components.
• Ability to work within cross‑functional global teams and liaise with authorities.

Required skills

• FDA pre‑submission and 510(k) processes
• EU MDR regulatory pathway
• TGA submission requirements
• ISO 13485 quality management
• ISO 14971 risk management
• 21 CFR 820 Quality System Regulation
• Post‑market surveillance management
• Regulatory impact assessment
• AI/ML medical device regulatory knowledge