Regulatory Affairs Specialist (Hybrid)

Requisition ID:6194

Job Title:Regulatory Affairs Specialist (Hybrid)

Job Country:United States (US)

Here at Avanos Medical, we passionately believe in three things:

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  Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;

  
  
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  Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;

  
  
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  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.

The Avanos COVID-19 Vaccine Policy: This Policy applies to U.S. customer-facing / field-based employees & Avanos leadership: All U.S. customer-facing / field-based employees hires must be fully vaccinated against COVID-19. Proof of being fully vaccinated does not need to be disclosed until a job offer has been made but must be submitted within 48 hours after the acceptance of the job offer. If you have a qualifying medical condition or sincerely held religious belief or practice that precludes you from receiving a COVID-19 vaccine, you may apply for an exemption or deferral after you accept the job offer and before your scheduled start date. The reasonable accommodation provided to the employee, if any, will depend on the employee's job and the applicable facts, but it may include weekly COVID-19 testing and masking requirements. New hires who do not submit, before their scheduled start date, proof of being fully vaccinated or a request for a reasonable accommodation will have their job offer revoked.

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 Regulatory Affairs Specialist is an individual contributor that works closely and partners with regulatory colleagues and other internal departments to efficiently and effectively meet assigned deliverables. The function of the position is to provide management of regulatory fees and licenses, procedures and processes implementation and registration support including publishing/verification support.

Job Position Accountabilities / Expectations

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  Prepare and maintain annual licenses, registrations/listings, and registration renewal documentation; arrange for required payments of registrations, listings, and submissions.

  
  
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  Support publishing of U.S., EU and Canada submission in compliance with geography-specific regulatory requirements.

  
  
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  Manage device and facility listings in FURLS database. Serve as official correspondent to regulatory agencies.

  
  
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  Lead verification and quality review of submissions and other responses to regulatory agencies to ensure compliance with internal documents and external regulatory agency guidelines.

  
  
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  Ensure compliance of Regulatory department procedures with external regulations, standards, guidelines, etc.

  
  
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  Track Regulatory department metrics for submissions, publishing, and other topics as requested.

  
  
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  Coordinate and prepare for RA related audits such as MDSAP

  
  
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  Support global registrations and product release for distribution.

  
  
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  Work with Regulatory department and other cross-functional teams, as required, to assist with interpretation of, compliance to, and communication regarding applicable standards and other regulatory agency requirements.

  
  
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  Ability to perform multiple tasks concurrently with a high level of accuracy

  
  
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  Other duties as assigned

  
  

Experience

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  Curious-you ask questions and do the research to get relevant and necessary information

  
  
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  Self-starter-you listen and learn with the intention of getting things done

  
  
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  Confident-despite being independent you aren't afraid to ask for advice when appropriate

  
  
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  Collaborative-you enjoy being a part of a team, listening colleagues' ideas, providing inputs, and working together to create excellent solutions

  
  
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  Discerning-you understand priorities and are adaptable to changing requirements

  
  
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  Driven-you seek challenges and opportunities to proactively affect change, refine your skillset, and develop in your field

  
  

Required Qualifications:

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  Bachelor's Degree, Prefer in Science, Engineering, or Related Field

  
  
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  Minimum 3 years technical experience in a regulated healthcare industry in functions such as RA, QA, R&D.

  
  
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  Demonstrated comprehensive technical writing skills.

  
  
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  Advanced Skills with Microsoft Programs: Word, Excel, PowerPoint and Project

  
  

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. Benefits on day 1!