Position: Quality, Regulatory & Compliance ManagerManager – Medical device
Quality, Regulatory & Compliance Manager Manager will play a crucial part in upholding industry standards, ensuring adherence to regulations, and maintaining the highest level of quality across our healthcare operations. If you’re ready to make a significant impact on patient care and safety, while leading a team towards excellence, we encourage you to apply and be a part of our mission-driven organization.
We are looking for Quality Regulatory Compliance Manager to lead and support quality assurance and regulatory affairs activities in accordance with local regulation and Corporate QMS in Thailand as well as partner and provide guidance to all internal team members and external stakeholders on QARA related matters.
- Implement and maintain Quality Management System (ISO 9001 & 13485) and Good Distribution Practice in Thailand, including coordinate annual inspection audit and management review activities.
- Report Adverse Event according to Thai FDA regulation and Global SOPs
- Coordinate with respective Sales and Service Unit (SSU) functional teams on ensuring that Field Safety Corrective Action is executed per local regulation and Global SOPs by Thailand SSU
- Oversee product registration activities, ensure product licenses are renewed on time to minimize business impact.
- Provide registration requirements for new projects / products development as well as product change.
- Build professional relationships with local regulatory authorities.
- Provide guidance and solutions to other departments on all matters relating to quality including regulatory compliance, including monthly status update.
- Lead and support implementation of Global SOPs at country level
- Bachelor’s degree in science background or related field
- Minimum 5 years of Quality, Regulatory or compliance related work experience
- Must have knowledge and understanding of Quality Management System, and regulatory of Good Distribution Practice requirements.
- Fluent spoken and written English and Thai
- Strong leadership and communication skills
- Resourceful and independent team player
- Mature, pro-active working attitude and able to work under pressure.
- A team player and a self-starter with strong inter-personal and presentation skill