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Senior Regulatory Affairs Manager

Company: Avanos
Location: Alpharetta
Posted on: April 8, 2021

Job Description:

Career Opportunities: Senior Regulatory Affairs Manager (2925) Requisition ID--2925-----Posted--02/19/2021-----Alpharetta Office-----United States-----Quality Assurance, Regulatory & Compliance----- Additional Posting Locations (2) Job Title:--Senior Regulatory Affairs Manager Job Country:--United States (US) Here at Avanos Medical, we passionately believe in three things:

  • Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
  • Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
  • Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.-- Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter.--We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit www.avanos.com . The role The Senior Regulatory Affairs (RA) Manager will be responsible for support of various regulatory medical device functions and its activities, including the development of global regulatory strategies to determine and pursue courses of action necessary to obtain regulatory product approvals. The manager will represent RA on cross functional teams and will partner closely with product development teams. The responsibility entails leadership in preparation of regulatory submissions required to market new or modified devices in both domestic and international markets. Additionally, this position leads the submission and correspondence activity to various regulatory bodies including FDA along with EU MDR notified bodies. Essential Duties and Responsibilities:
    • Strategic planning and execution for successful timely, compliant submissions for product registrations in the U.S, EU and Canada and to provide support to ROW registrations.
    • Provide product lifecycle regulatory support for currently marketed devices to assess change requests, labeling and promotional material to ensure compliance with regulations and guidance documents, including product modifications that require regulatory body clearance/approval or notification prior to commercialization of a changed product.
    • Ensure Software is developed and validated to standards required for FDA regulated products.
    • Regulatory Intelligence-Interpret and apply regulations and associated U.S. FDA and Canada documents working to actively monitor and communicate changes within the organization. Apply to business practices evaluating risk and proposed solutions to organizational challenges.
    • The creation, training and implementation of business processes
    • Support and lead engaging interactions with regulatory agencies as part of submission review and internal/external audits. Required:
      • Bachelor's Degree in Science, Engineering or related field
      • Minimum of 5 years within Regulatory Affairs in the Medical Industry, ideally in Medical Device.
      • Authoring and leadership of 510(k) submissions and EU technical file/documentation review by notified bodies.
      • Experience managing global regulatory initiatives across an organization
      • Effective and clear oral and written communication
      • Demonstrated facilitation and issue resolution skills
      • Ability to work cooperatively at all levels in a matrix environment to build and maintain positive relationships required to accomplish organization goals.
      • Demonstrated capacity for strategic creative and effective thinking, project planning and project management
      • Self-motivated and open to learn and actively listen
      • Seeks out challenges and opportunities and proactively resolves
      • Strong attention to detail, highly organized with effective time management, with ability to manage multiple projects simultaneously. Respectful relationships
      • Successful coaching and guidance to team members with both abilities to work independently or collaboratively.
      • Ability to travel up to 10% at times. Preferred:
        • Master's Degree in Science, Engineering or related field
        • Regulatory Affairs Certification (RAC)
        • Experience with Medical Device Software Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here . Join us at Avanos
          Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.

          Make your career count
          Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting. free onsite gym - onsite cafeteria - benefits on day 1 - uncapped sales commissions - HQ region voted 'best place to live' by USA Today

Keywords: Avanos, Alpharetta , Senior Regulatory Affairs Manager, Executive , Alpharetta, Georgia

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