Regulatory Affairs Specialist

About This Role

This role involves developing and executing regulatory strategies for innovative medical devices, software, and AI-enabled technologies. The specialist will help bring these products to market across the US, Europe, and Australia, working as a key member of the Enabling Tech team within a global Regulatory Affairs team.

Responsibilities

• Develop and execute regulatory strategies for new and existing medical devices and software
• Lead and support regulatory submissions, including FDA 510(k), EU MDR technical documentation, and TGA submissions
• Work closely with Engineering, Clinical, Quality, and Product Development teams throughout the product lifecycle
• Provide regulatory guidance on product development, risk management, clinical evidence, testing, labeling, and product changes
• Interact with FDA, Notified Bodies, and TGA and support pre-submission meetings
• Support post-market activities, regulatory assessments, audits, CAPAs, and product changes
• Help develop regulatory strategies for emerging technologies, including AI and machine learning
• Monitor regulatory changes and advise the business on new requirements

Requirements

• Bachelor’s degree in Science, Biomedical Engineering, Regulatory Affairs, or a related field
• 5+ years of experience in medical devices, healthcare, or a related industry
• Experience with regulatory submissions in the US and Europe; TGA experience is a plus
• Strong knowledge of FDA regulations, EU MDR, ISO 13485, and ISO 14971
• Excellent communication, analytical, and problem-solving skills
• Ability to work independently while collaborating effectively with international, cross-functional teams

Nice to have:

• Experience with software/SaMD, AI, or machine learning

Benefits

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

Important Details

• Travel: up to 10% of the time

About the Company

Enovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. The company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.