Senior Regulatory Specialist – MedTech & AI Devices

enovis; Austin (TX); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Job summary

Enovis in Austin, TX seeks an experienced Regulatory Affairs Specialist to develop and execute regulatory strategies for medical devices, software, and AI-enabled technologies. You will lead submissions to FDA 510(k), EU MDR, and TGA, and collaborate with engineering, clinical, quality, and product development teams.

The role requires a bachelor’s in science or related field, 5+ years in medical devices, and strong knowledge of FDA regulations and ISO standards.

Qualifications

• Bachelor’s degree in a science or engineering field and Regulatory Affairs preferred.
• 5+ years of experience in medical devices or related industry.
• Experience with FDA and EU regulatory submissions; TGA a plus.
• Strong knowledge of FDA regulations, EU MDR, ISO 13485, and ISO 14971.
• Experience with software/ SaMD, AI, or ML is a strong advantage.
• Excellent communication and ability to work with cross-functional teams.

Responsibilities

• Develop and execute regulatory strategies for medical devices and software.
• Lead and support regulatory submissions (FDA 510(k), EU MDR, TGA).
• Collaborate with Engineering, Clinical, Quality, and Product Development teams.
• Provide regulatory guidance on development, risk management, and labeling.
• Engage with FDA, Notified Bodies, and regulatory authorities on submissions.
• Support post-market activities, audits, CAPAs, and product changes.
• Develop strategies for AI and machine learning technologies.
• Monitor regulatory changes and advise on new requirements.

Skills

Regulatory affairs

Medical devices

FDA regulations

EU MDR

Cross-functional collaboration

Communication skills

AI/ML experience

Education

Bachelor’s degree in Science, Biomedical Engineering, Regulatory Affairs, or related field

Job description

Enovis in Austin, TX seeks an experienced Regulatory Affairs Specialist to develop and execute regulatory strategies for medical devices, software, and AI-enabled technologies. You will lead submissions to FDA 510(k), EU MDR, and TGA, and collaborate with engineering, clinical, quality, and product development teams.

The role requires a bachelor’s in science or related field, 5+ years in medical devices, and strong knowledge of FDA regulations and ISO standards.