Regulatory Affairs Specialist

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

Who We Are

ABOUT ENOVIS™

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, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

What You'll Do

At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself

As a key member of the Enabling Tech team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Regulatory Affairs Specialist

Reports To:

Regulatory Affairs Manager

Location:

Austin, TX

Business Unit Description:

Enabling Technologies

Job Title/High-Level Position Summary:

Orthopedic Medical Devices & Digital Health

We are looking for an experienced Regulatory Affairs Specialist to join our global Regulatory Affairs team. In this role, you will develop and execute regulatory strategies for innovative medical devices, software, and AI-enabled technologies, helping bring them to market across the US, Europe, and Australia.

Key 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.

Minimum Basic Qualifications:

• 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.
• Experience with software/SaMD, AI, or machine learning is a strong advantage.
• Excellent communication, analytical, and problem-solving skills.
• Ability to work independently while collaborating effectively with international, cross-functional teams.

Why Join Us?

• This is an exciting opportunity to work at the intersection of medical devices, orthopedic innovation, software, and AI.
• You’ll have the opportunity to influence innovative products from development through market launch and help deliver technologies that improve surgical precision and patient outcomes.

Working Environment

• Primarily office-based
• Occasional travel to manufacturing and clinical sites and surgeon workshops
• Hands-on exposure to surgical instruments, navigation systems, and innovative medical technologies

Travel Requirements:

• Must be able to travel up to 10% of the time.

Desired Characteristics:

• Experience with software/SaMD, AI, or machine learning is a strong advantage.
• Excellent communication, analytical, and problem-solving skills.
• Ability to work independently while collaborating effectively with international, cross-functional teams.

"Creating better together". It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

We offer a comprehensive benefits package that includes:

• 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

Join us in creating better together.

EQUAL EMPLOYMENT OPPORTUNITY

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.