Regulatory Affairs Specialist

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 Regulatory 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:
Director, Regulatory Affairs I Foot & Ankle

Location:

Atlanta or Houston Facility (Hybrid schedule is available with three days on-site.)

Business Unit Description:

Foot and Ankle

We are seeking a skilled and experienced Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will be supporting a wide range of regulatory activities to ensure compliance with global submission requirements, departmental processes, and quality system standards. This role will develop regulatory strategies, complete impact assessments, and prepare submissions including U.S. FDA 510(k)s, EU MDR Technical Documentation and other OUS registrations. The RA Specialist will support the Foot & Ankle Business Unit (F&A BU), contribute to new product development and sustaining projects, and engage with global regulatory authorities including the FDA and EU Notified Body.

Key Responsibilities: The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.

• Provide regulatory guidance and support to cross-functional teams for both new product development and sustaining projects.

• Complete regulatory deliverables for assigned projects, including strategy development, impact assessments, and submission preparation through to clearance or approval.
• Prepare global submissions including but not limited to U.S. FDA 510(k) Premarket Notifications, PMA submissions, EU MDR Technical Documentation, and other international product registrations
• Collaborate with cross-functional teams to collect and review technical documentation, ensuring accuracy, regulatory compliance, and timely submissions.
• Communicate and negotiate with global regulatory bodies during submission reviews, audits, and post-market activities.
• Identify risks and develop contingency plans for assigned regulatory projects.
• Interpret and communicate regulatory requirements and guidance to internal teams and stakeholders.
• Maintain regulatory databases, trackers, and documentation in accordance with internal procedures and applicable regulations.
• Support compliance-related activities such as site registrations, audits, and post-market surveillance (e.g., HHEs, MDRs, FAs, CAPAs).
• Apply quality system knowledge to all job functions.
• Perform additional tasks as assigned by the Regulatory Manager.
• Comply with Enovis's Code of Conduct, company policies, procedures, and standards.

Minimum Basic Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor's degree in a scientific discipline (e.g., biology, microbiology, chemistry, engineering, or medical technology).

• Minimum 2 years of regulatory affairs experience in the medical device industry.
• Proven experience preparing U.S. FDA 510(k) submissions.
• Understanding of design and change control processes, regulatory assessments, and quality system requirements under ISO 13485 and FDA QSR.
• Experience working cross-functionally and with regulatory agencies.
• Ability to travel 20%

Desired Characteristics:

• Experience with international registrations and submissions including EU MDR.

• Knowledge of medical device labeling and associated regulations.
• High attention to detail with a focus on accuracy and completeness.
• Strong written and verbal communication skills.
• Excellent organizational, planning, and time management abilities.
• Analytical and problem-solving mindset.

Work environment | Physical demands:

• Ability to sit and stand for long periods of time.

Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

"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

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.