Regulatory Affairs Specialist

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.

What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors:

Our Enovis Purpose, Values and Behaviors on Vimeo

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.