Senior Regulatory Affairs Specialist

Responsibilities

• Develop and execute global regulatory strategies for new product development, including hardware and Software as a Medical Device (SaMD).
• Prepare and manage regulatory submissions and technical documentation for the US, EU, and Australian markets.
• Lead pre-submission meetings with the FDA, Notified Bodies, and TGA.
• Act as the regulatory representative on cross-functional product development teams, providing input on risk management, verification, and validation.
• Perform regulatory impact assessments for product or process changes, including 510(k)s, letters to file, and technical file updates.
• Review labeling, marketing collateral, and training materials to ensure compliance with global regulations and approval conditions.
• Manage regulatory-related CAPAs, driving root cause investigations and implementing effective corrective actions.
• Support post-market surveillance activities and participate in technical documentation audits.

Requirements

• Bachelor's degree in science, biomedical engineering, regulatory affairs, or a related field.
• 7–8 years of regulatory affairs experience within the medical device or healthcare industry.
• Proven expertise in US, EU, and TGA regulations.
• Strong experience preparing 510(k) submissions and EU Technical Documentation.
• In-depth knowledge of ISO 13485 and ISO 14971 standards.
• Ability to work independently and collaborate effectively across a large, global organization.

Preferred Qualifications

• Experience working with products involving machine learning or artificial intelligence.
• Experience with international regulatory submissions beyond the US, EU, and Australia.

Benefits

• Medical, Dental, and Vision Insurance
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Spending and Savings Accounts
• Income Protection Plans
• Legal Services

About the Company

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent, and innovation, Enovis's extensive range of products and integrated technologies fuels active lifestyles in orthopedics and beyond.