Senior Regulatory Affairs Specialist – Medical Devices

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 product launches in the United States, European Union, and Australia while ensuring compliance with global quality standards.

Key responsibilities

• Develop and execute global regulatory strategies for new and modified orthopedic products.
• Prepare and manage submissions to FDA, Notified Bodies, and TGA, including pre‑submission meetings.
• Coordinate cross‑functional teams to align product development with regulatory requirements.
• Lead post‑market surveillance activities and regulatory impact assessments for product changes.
• Support the integration of machine‑learning and artificial‑intelligence features within the product portfolio.

Required profile

• Several years of regulatory affairs experience in medical devices, preferably in orthopedics.
• Demonstrated ability to navigate US, EU, and Australian regulatory pathways.
• Strong understanding of quality system regulations such as ISO 13485, ISO 14971, and 21 CFR 820.
• Experience with SaMD and emerging technologies like AI/ML.

Required skills

• FDA regulatory submissions
• EU MDR compliance
• ISO 13485 implementation
• ISO 14971 risk management
• 21 CFR 820 quality system knowledge
• TGA regulatory requirements
• SaMD regulatory expertise
• Machine‑learning and AI regulatory considerations