Quality Systems Compliance Specialist

Avanos Medical - Atlanta Metropolitan Area

Hiring: Quality Systems Compliance Specialist Company: Avanos Medical Location: Atlanta Metropolitan Area Job Posted Time: 2026-09-10 10:40:43 Employment Type: Hybrid Target Skills & Keywords : Microsoft Excel, Project Management, R, Risk Management About the job Experience: •5 years of experience in Regulatory Affairs, Quality, engineering, or another regulated environment Required Skills: •This is a forward-looking, analytically driven role that bridges quality systems management and regulatory strategy. The Quality Systems Compliance Specialist ensures the organization is always aware of and up-to-date on new or upcoming regulatory changes and that the organization’s QMS is continuously positioned to meet and address those changes. •Monitor changes to FDA regulations, standards and guidance documents. •Monitor Federal Register, EU Official Journal, global competent authorities’ websites, and public consultation portals on a defined, documented schedule. •Monitor standards development pipelines through ISO, IEC, ASTM, and AAMI for emerging standards that may affect the QMS or product requirements. •Analyze new and proposed regulatory requirements and standards updates to assess their impact on the QMS, products, processes, and submissions. •Monitor global material, chemical, sustainability requirements (ROHS, REACH, SCIP, TSCA etc.) •Identify gaps between current QMS procedures and new or updated regulatory requirements and recommend remediation actions with appropriate lead times. •Communicate changes and trends to relevant functions and ensure the gaps are addressed in a timely manner. Qualifications: •Bachelor’s degree in sciences, compliance, regulatory affairs •Minimum of 5 years of experience in Regulatory Affairs, Quality, engineering, or another regulated environment •Strong working knowledge of global medical device regulations, guidance documents, and standards •Demonstrated analytical and technical writing skills •Excellent verbal communication and ability to clearly explain complex topics •Strong project management capability and attention to detail •Demonstrated capacity to work independently and manage multiple priorities •Demonstrated ability to build cross-functional relationships and influence without authority •This role follows a Hybrid schedule and will require to be at the Alpharetta Office Tuesday through Thursday •Operational familiarity with change control, labeling, submissions, or risk management Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!