New

RAQA Senior Specialist

Avanos Medical

United States, Georgia, Alpharetta

5405 Windward Parkway (Show on map)

Aug 28, 2025

Job Description

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.

RA Relevant Activities

To support RAQA Manager in Japan, regarding below items

To support regulatory change administration for Medical Devices (MD) and discuss with Japanese regulatory agencies (PMDA/MHLW).
To support documentation and administration for documents relevant to Regulator Affairs (e.g.IFU/package insert/product label, regulatory description for products, Product Master Formula).
To support regulatory compliance for business issues arising from business function. (e.g.advertisement and promotion materials for products).
To support administration of manufacturing sites relevant to MD marketing approval.
To support a new registration/re-registration and administration for QMS on MD marketing approval.
To discuss and collaborate with counterparts of overseas headquarters/production and development sites.
To support company's projects from a country/global side. (e.g.Kaizen project)
To support in reviewing and submitting change controls to assess the impact of change and consequent regulatory submission requirements, perform due diligent assessment.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and propose solutions with relevant stakeholders.
To support keeping abreast with current and latest regulations in Japan; provide assessment on impact of new, existing and pending regulations, guidelines or standards to internal stakeholders in timely manner.
Any other ad-hoc duties or projects as required by the management team.

QA Relevant Activities

Responsible for quality systems, post marketing surveliance and regulatory compliance to ensure process and product conformance to Japan regulation and Avanos requiment.
Maintain and/or enhance Quality functional system in compliance with MHLW Ordinance requirements including but not limited to Ordinance 87,94,135,169 in manner that effectively support growth for Avanos Medical Japan.
Proactively to assist audits from Japanese government to Avanos manufacturing facilities and Avanos Medical Japan office.
In case of being assigned as QMS repesentatives, General Marketing Manager and/or QMS Management representative, to be responsible for matters specified on Quality Manual or SOPs.
Maintain Quality system documents and QMS lincese, supporting and leading internal/external audits. Also maintain QMS and assist each function to set up related operational processes.
If needed, coordinates and follows up CAPA or equivalents implementations as applicable.
Develops, when necessary local procedures or work instructions to comply with local regulations tha do not conflict Avanos Japan quality management system.

GVP Relevant Activities

GVP Ordinance 145 (Revises GVP manuals and develop various officialdocuments, creates collection work processes, works on safety managementrelated information).
Complaint handling and reporting. Assures regions report within compmay's time manner after translation if required, and according to relevant BU requirements.
Coordinating and obtaining necessary information between customers, sales representatives and Customer Quality.
Supports,if required,the return of devices for analysis, following BU's requirements and company processes.
Performs other related duties as assigned by management.
Works with Customer Quality, Quality Engineering and and relevant functions to obtain customer traceability list for the country/region, if required.
Communicate with customers, if required, as per the timelines provided by the relevant BU / Sales team.
Report all the applicable field actions to PMDA and relevant authorities as applicable.

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.