Senior Manager, Regulatory Affairs & Quality Assurance, APAC

Requisition ID:6822

Job Title:Senior Manager, Regulatory Affairs & Quality Assurance, APAC

Job Country:Singapore (SG)

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. 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

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets where Avanos operates. Partner with global and regional stakeholders to ensure full compliance with regulatory requirements, support business objectives, and strengthen the RA/QA capability across the region.

Job Position Scope

APAC regulatory leadership and oversight across product registrations, quality systems, compliance processes, RA/QA team development, distributor/license-holder engagement, and interactions with Health Authorities.

Job Position Accountabilities / Expectations

• Serve as an active member of the Global Regulatory & Clinical Affairs, Global Quality, and APAC Leadership Teams, working closely with cross-functional stakeholders to achieve APAC and global business goals.
• Provide Regulatory and Quality leadership across all APAC markets.
• Recruit, build, and develop in-country RA/QA teams through coaching, mentoring, and capability-building initiatives.
• Advise APAC cross-functional teams and Global RA & Clinical Affairs and Global Quality functions on regional regulatory requirements.
• Oversee the preparation, submission, and lifecycle maintenance of product registrations across APAC.
• Maintain regulatory databases as a reliable reference for regional and global teams.
• Direct the development and maintenance of regulatory systems and processes to ensure compliance with local regulations while aligning with the Global Quality Management System.
• Develop APAC regulatory strategies to enable product growth and business initiatives.
• Lead interactions with Health Authorities across APAC as required.
• Manage relationships with APAC distributors and license holders relating to product registrations, regulatory compliance, quality compliance, and post-market reporting.
• Manage the regional RA/QA budget in alignment with APAC business objectives.
• Conduct regulatory due diligence for M&A activities when required.
• Lead change request assessments and regulatory submissions to meet agreed timelines.
• Oversee technical and scientific regulatory activities as assigned.
• Stay current with regional and international regulations, standards, and emerging requirements.
• Provide RA/QA leadership to assigned project teams.
• Demonstrate proactive problem-solving and the ability to propose alternative solutions to internal and external stakeholders.
• Foster curiosity and continuous learning within the team.
• Mentor and develop the APAC QA/RA team and strengthen the team’s overall capability and performance.

Key Relationships / Customer Expectations

• Internal:Sales & Marketing, Regional Management, Customer Service, Supply Chain, Quality, Regulatory, Operations/Manufacturing, Research & Engineering, and other internal teams requiring RA/QA support.
• External: Regulatory bodies and certification bodies in APAC, distributors and license holders, customers, and regional service vendors or consultants for outsourced RA/QA activities.

Key Leadership Behaviors

• Demonstrate openness, candor, and respect for diverse perspectives.
• Prioritize effectively and deliver results in a timely manner.
• Anticipate customer needs and drive innovation in regulatory and quality practices.
• Develop and coach team members and remain accountable for building a strong, diverse RA/QA function.
• Coach and influence others to strengthen RA/QA practices and behaviors across the company.

Qualifications / education / experience / Skills Required

• Bachelor’s degree in a relevant scientific or technical discipline.
• 6-10 years of experience in the medical device industry.
• Proven leadership experience with a track record in managing teams and developing long-term strategic initiatives.
• Strong written and verbal communication skills.
• Experience with regional or international regulatory submissions preferred.
• Strong computer proficiency.

Specialized or Essential Knowledge Required

• Understanding of regulatory requirements across major APAC markets.
• Familiarity with mandatory Quality Management System requirements across APAC.
• General knowledge of US FDA regulations (21 CFR, FDA guidelines) and EU CE marking processes is an advantage.

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.