Head of Quality Management and Regulatory Affairs, APAC

Siemens seeks an Executive to lead Quality Management and Regulatory Affairs across the APAC region, ensuring compliance, safety, and operational excellence while managing a high-performing team.

This executive role is responsible for steering the Quality Management and Regulatory Affairs function throughout the Asia-Pacific area. The position ensures that all operations meet strict compliance standards and product safety requirements, serving as the designated Quality Representative for assigned legal entities while driving operational excellence.

Responsibilities

• Oversee and enhance the Quality Management System (QMS) on an ongoing basis.
• Guarantee the proper implementation of Quality Assurance and Engineering procedures.
• Detect and reduce quality risks associated with commercial activities.
• Implement process improvements to boost efficiency and customer satisfaction.
• Prepare for inspections and manage both internal audits and external regulatory reviews.
• Formulate and carry out the regional regulatory strategy.
• Ensure strict adherence to internal policies and external legal regulations.
• Act as the primary liaison with health authorities and other external stakeholders.
• Create a governance framework for Commercial and Customer Services teams.
• Manage Post Market Surveillance and ensure timely, accurate reporting.
• Recruit, mentor, and lead a high-performing regional Quality and Regulatory team.
• Collaborate closely with global Quality departments and cross-functional partners.

Requirements

• 10–15+ years in Quality and/or Regulatory Affairs within medical device / pharma, including leadership responsibility.
• Strong experience with QMS, regulatory submissions/approvals, inspections, and product safety/compliance frameworks.
• Proven track record in international, matrix organizations and multi-market environments.
• Degree in life sciences, engineering, or related field.
• Fluent in English.

About the company

Siemens Healthineers is a global leader in medical technology, dedicated to pushing boundaries to create better outcomes for patients. The organization comprises a team of more than 73,000 highly dedicated Healthineers operating in more than 70 countries.

• A global team of more than 73,000 highly dedicated Healthineers in more than 70 countries.
• Leader in medical technology pushing boundaries to create better outcomes for patients.