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Regulatory Affairs Specialist

at Colfax Corporation in Wilmington, Delaware, United States

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 .

Enovis History
In April of 2022, Colfax, which includes orthopedic leader , separated from ESAB Corporation and rebranded to Enovis. In recognition of our successful history of growth and innovation, the distinctive "O" in our new Enovis logo was deliberately carried over from our Colfax logo as it represents continuous improvement - a cornerstone of our business's success that will continue at Enovis. Enovis is poised to become one of the world's leading medical technology companies
What You'll Do
Job Summary:
The Regulatory Affairs Specialist will work with supervision to bring new and modified medical devices to market and ensure ongoing compliance. The Regulatory Affairs Specialist will be the regulatory representative on product development teams and will be responsible for developing regulatory strategies, authoring submissions, and assessing design and manufacturing changes for wide range implantable products.

Required Qualifications
Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle.
Develops and executes regulatory strategies for new and modified products.
Works with regulatory and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies.
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 prepares regulatory submissions for new and modified products ensuring compliance with applicable regulatory requirements and company policies.
Handles the preparation and processing of documentation required for new product introductions and revised products in international markets.
Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
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.

Preferred Qualifications
Bachelor's degree with a minimum of 2 years of medical device industry experience
Prior experience with regulatory submissions, such as PMA or 510(k)
Working knowledge of FDA and international regulations for medical devices
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

EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

"EOE AA M/F/VET/Disability

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws."        
        
        

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Job Posting: 1072852

Posted On: Nov 13, 2022

Updated On: Dec 13, 2022

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