Regulatory Affairs Specialist - Austin - Enovis

    Enovis
    Enovis Austin

    1 week ago

    Description
    Who We Are
    ABOUT ENOVISTM
    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
    What You'll Do
    At EnovisTM 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 Affairs 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:
    Sr, Director, Regulatory Affairs | Surgical
    Location:
    Austin, TX - Hybrid (3 days onsite | 2 days remote)
    Job Title/High-Level Position 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.
    Key Responsibilities:
    • 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.
    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.
    Minimum Basic 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
    "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
    EOE AA M/F/VET/Disability Statement

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