Regulatory Market Access Specialist

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 team, you will play an integral part in helping Enovis drive the medical technology industry forward by transforming patient care and improving patient outcomes.

Job Title

Regulatory Market Access Specialist

Role Summary

The Regulatory Market Access Specialist will work in the market access team to bring new and modified medical devices to market and ensure ongoing compliance. The Regulatory Market Access Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and preparation of submissions. The Regulatory Market Access Specialist performs regulatory submission/approval activities for specific Enovis products. The Regulatory Market Access Specialist ensures compliance with required regulations and established corporate standards. The Regulatory Market Access Specialist ensures that product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Market Access Specialist will exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks.

 

Key Responsibilities

• Handles the preparation and processing of documentation required for new product introductions and modified products in international markets.
• Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle.
• Works with market access team and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies in international markets.
• Prepare documentation for international regulatory registrations and licenses
• Define regulatory requirements necessary for regulatory approval of Surgical for the countries under his/her responsibility
• Manages the release and shipment of products under regulatory controls to all regions.
• Provides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements.
• Coordinates and assists the Market Access Lead with defining regulatory requirements in Regulatory planning process.
• Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations and sends applicable notifications to license and registration holders in international markets.
• Maintain all regulatory documentation to ensure availability for external audits and preparation of submission packages
• Provides technical guidance and regulatory training to cross-functional teams.
• Reviews device labeling and advertising materials for compliance with applicable regulations and recommends appropriate changes.
• Monitor the development of new regulatory requirements and advise of the impact to cross-functional teams.
• Develops and maintains procedures to ensure compliance and support business goals.
• Maintains proficiency in government regulations and guidances.
• Support other regulatory requests or projects as needed.
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Preferred Qualifications

• Bachelor's degree with a minimum of 2 years of medical device industry experience as a Regulatory Specialist
• Prior experience with regulatory submissions for medical devices in European and international markets
• General understanding of the product development process and design controls
• Ability to manage several projects simultaneously
• Strong interpersonal and influencing skills
• Ability to independently manage projects, prioritize time and communicate effectively
• Excellent command of English (spoken and written).
• 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. Visit www.enovis.com to learn more.
  
  

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 which includes:

• Medical, Life, and Accidental Insurance
• Leaves and Holidays
• EQUAL EMPLOYMENT OPPORTUNITY Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and 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.
  
  

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.