Quality Systems Compliance Specialist

Avanos Medical; Alpharetta (GA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Avanos Medical is seeking a Quality Systems Compliance Specialist in the United States with a focus on monitoring regulatory changes and maintaining an up-to-date QMS. The role serves as the primary resource for horizon-scanning, enforcement trends, and impact assessment across global markets.

The position requires a minimum of five years in Regulatory Affairs or a related field, a strong background in medical device regulations, and excellent analytical writing and communication skills.

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.
• This role follows a Hybrid schedule and will require to be at the Alpharetta Office Tuesday through Thursday.

Responsibilities

• 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.
• Monitor FDA Form 483 inspectional observations, Warning Letters, and Field Safety Notices (FSNs/FSCAs/Recalls) issued across the medical device industry to identify enforcement trends, recurring citations, real-world failure modes, and post-market safety patterns. Compile, assess and communicate findings and trends to proactively strengthen the organization's own quality management systems and reduce exposure to similar issues.
• 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.
• Assess transition timelines and grace periods for regulatory changes, ensuring the organization has adequate time to respond and adapt.
• Prepare and distribute regulatory intelligence briefings, horizon-scanning reports, and compliance alerts to relevant internal stakeholders including Quality, Regulatory Affairs, R&D, Sustaining Engineering, Manufacturing, Supply Chain, Clinical Affairs, Legal, Marketing, and Senior Leadership.
• Manage and support QMS document updates such as SOPs, work instructions, forms, and policies in response to identified regulatory changes, enforcement trends, and lessons learned from industry 483s, Warning Letters, and FSNs.
• Represent the company in industry working groups, trade association regulatory committees, and standards development activities as appropriate.

Skills

Regulatory affairs

Analytical writing

Verbal communication

Project management

Cross-functional collaboration

Independent work

Horizon-scanning

Education

Bachelor's degree in sciences, compliance, regulatory affairs

Job description

Job Title:Quality Systems Compliance Specialist

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. For more information, visit www.avanos.com .

The Role

The Quality Systems Compliance Specialist is responsible for proactively monitoring, analyzing, and communicating changes in the global regulatory and quality standards landscape relevant to the organizations products, processes and markets, to ensure the organization's Quality Management System (QMS) remains current, compliant, and strategically aligned with evolving requirements. This role serves as the organization's primary resource for regulatory horizon-scanning, standards tracking, enforcement monitoring, and quality and compliance impact assessment. This person translates complex regulatory developments into actionable intelligence for quality, regulatory and leadership teams.

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.

Responsibilities

• 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.
• Monitor FDA Form 483 inspectional observations, Warning Letters, and Field Safety Notices (FSNs/FSCAs/Recalls) issued across the medical device industry to identify enforcement trends, recurring citations, real-world failure modes, and post-market safety patterns. Compile, assess and communicate findings and trends to proactively strengthen the organization's own quality management systems and reduce exposure to similar issues.
• 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.
• Assess transition timelines and grace periods for regulatory changes, ensuring the organization has adequate time to respond and adapt.
• Prepare and distribute regulatory intelligence briefings, horizon-scanning reports, and compliance alerts to relevant internal stakeholders including Quality, Regulatory Affairs, R&D, Sustaining Engineering, Manufacturing, Supply Chain, Clinical Affairs, Legal, Marketing, and Senior Leadership.
• Manage and support QMS document updates such as SOPs, work instructions, forms, and policies in response to identified regulatory changes, enforcement trends, and lessons learned from industry 483s, Warning Letters, and FSNs.
• Represent the company in industry working groups, trade association regulatory committees, and standards development activities as appropriate.

Qualifications

Required:

• 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
• Ability 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

Preferred:

• Experience with regulatory intelligence, standards management, or external requirements
• Experience with ISO/IEC/ANSI/AAMI standards and implementation processes
• Familiarity with change control, labeling, submissions, or risk management
• Experience participating in standards committees or industry working groups
• Experience with regulatory intelligence tools or surveillance databases (e.g., Cortellis, RAPS, MAUDE, standards dashboards)
• Knowledge of global medical device regulatory frameworks (FDA, EU MDR/IVDR, Health Canada, APAC, LATAM, EMEA).
• Understanding of the relationship between standards, design controls, risk management, manufacturing and market access.
• Ability to synthesize complex information into executive-facing recommendations.

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

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.

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.

Avanos also offers the following:

benefits on day 1

free onsite gym

onsite cafeteria

HQ region voted 'best place to live' by USA Today

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