Senior Manager, Regulatory Affairs & Quality Assurance, APAC

• 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
• Serve as an active member of the Global Regulatory & Clinical Affairs, Global Quality, and APAC Leadership Teams
• Provide Regulatory and Quality leadership across all APAC markets
• Recruit, build, and develop in-country RA/QA teams
• 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
• Direct the development and maintenance of regulatory systems and processes
• Develop APAC regulatory strategies
• Lead interactions with Health Authorities across APAC
• Manage relationships with APAC distributors and license holders
• Manage the regional RA/QA budget
• Conduct regulatory due diligence for M&A activities
• Lead change request assessments and regulatory submissions
• Oversee technical and scientific regulatory activities
• Stay current with regional and international regulations, standards, and emerging requirements
• Provide RA/QA leadership to assigned project teams
• Demonstrate proactive problem-solving
• Foster curiosity and continuous learning within the team
• Mentor and develop the APAC QA/RA team

• 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
• 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

General knowledge of US FDA regulations (21 CFR, FDA guidelines) and EU CE marking processes is an advantage

• comprehensive and competitive range of benefits
• health care benefits
• retirement plans
• work/life benefits