MUST RELOCATE TO SINGAPORE / CHINA
My client is a global medical device manufacturer that develops and produce medical device mainly in the endovascular and cardiovascular space.
They are currently looking for a Director Regulatory Compliance to oversee the regulatory compliance activities and support audits
Responsibilities:
- Develop and Maintain Procedures: Lead the creation and upkeep of global procedures and coordinate the implementation and maintenance of IT systems related to the Global Quality Management System (QMS).
- Manage Change and Compliance: Oversee change management initiatives across sites and ensure regulatory compliance through corporate audits, external inspections, and ongoing monitoring activities.
- Monitor CAPA and Regulatory Notifications: Track and verify Corrective and Preventive Actions (CAPA), manage regulatory notifications, and support critical audits and inspections.
- Oversee QMS Operations and Risk Management: Supervise routine QMS operations, identify and report compliance risks to leadership, and organize Global Management Reviews and Monthly Global RC meetings.
- Support Continuous Improvement and Projects: Analyze findings to drive QMS improvements, provide compliance support for key projects such as Marketing Authorization Holder (MAH) initiatives, and perform additional tasks as assigned by leadership.
Requirements:
- Bachelor degree in Engineering, life science or other related field.
- More than 7 years of hands on experience on regulatory compliance management specifically in the medical device industry
- Experience in CDMO is preferred
- Familiar with ISO 13485 and US FDA
- Strong communication skills and good team player
If you are interested, please apply with your CV attached.
