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 launch initiatives across the United States, European Union and Australian markets while ensuring compliance with relevant regulations.

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 to shape clinical development plans.
• Manage post‑market surveillance and regulatory impact assessments.
• Provide regulatory subject‑matter expertise for machine‑learning and AI enabled technologies.
• Ensure compliance with TGA, EU MDR, ISO 13485, ISO 14971, 21 CFR 820 and company quality standards.

Required profile

• Proven experience in medical‑device regulatory affairs, preferably in orthopedics.
• In‑depth knowledge of US (FDA), EU (MDR), and Australian (TGA) regulatory frameworks.
• Ability to work within cross‑functional global teams.
• Strong understanding of post‑market requirements and clinical strategy alignment.

Required skills

• Regulatory submissions (FDA, Notified Body, TGA)
• EU MDR compliance
• ISO 13485
• ISO 14971
• 21 CFR 820
• Post‑market surveillance

What we offer

• Opportunity to influence cutting‑edge orthopedic technologies.
• Collaborative, innovation‑driven environment.
• Competitive compensation and benefits package.