Regulatory Affairs Specialist

Job Description

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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 our 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 .

Job Position Purpose / Summary

The Regulatory Specialist reports to the Quality and Regulatory Affairs (Sr.) Director and, depending on the organizational structure and the business needs, supports regulatory compliance throughout the organization and one or multiple aspects of the Quality Management System.

Job Position Accountabilities / Expectations

• Quality :
• Supports the organization to ensure an adequate and effective quality management system, supports the quality policy and sustains a quality culture.

The Regulatory Affairs Specialist is accountable to execute the following activities in the context of the QA / RA team :

• Maintain regulatory affairs files (e.g., registrations and CE-certificates, quality certificates, and device / facility licenses) and distribute information as required to support key stake-holders.
• Maintain an organized overview of applicable market authorizations and licences in the RA database.
• Develop and execute submission strategies to obtain clearance of international product registations in line with the applicable regulations.
• Ensure documentation meets EU MDR and other applicable regultions requirements to allow correct CE-certifications.
• Support and participate in audits performed by internal and external bodies.
• Support international sales and marketing with identification of regulatory registration requirements.
• Monitor regulatory developments and interpretation in EU by linking into available network through MedTech EU, EC commission resources, NB resources etc.
• Actively engage in development and implementation of regulatory projects.
• Follow-up, track and assemble regulatory commitments to Regulatory Agencies as required.
• Act as key interface and represent Avanos with local regulatory authorities and CE-certification agencies.
• Assist in preparation and execution of Field Action activities.
• Assist in the resolution of Quality Notifications and CAPAs as required.

Qualifications / Education / Experience / Skill Required

Required Qualifications :

• Minimum of 3 years of experience within Healthcare environment.
• University degree or related diploma.
• Experience with Excel, Word, PowerPoint and Outlook is required.
• Fluent in English.
• At least 3-5 years experience in Quality and / or Regulatory Affairs.
• RAC certification is a plus

Key Attributes

• Ability to manage communication with regulatory authorities with a high level of professionalism
• Strong interpersonal skills and a positive attitude.
• Sound analytical skills (good attention to detail).
• Drive, energy and enthusiasm for meeting and exceeding expectations.
• Hands-on in a fast moving environment and able to work with little supervision.

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, religion, sex, national origin, disability status, etc.

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.

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6 days ago