Executive recruitment consultant Monroe Consulting Group Indonesia is recruiting on behalf of Multinational Medical Device Company. Our client is seeking for RAQA Lead position. This job will be based in Jakarta, Indonesia.
Responsibilities:
Quality Assurance:
- Lead the development, implementation, and maintenance of the company's quality management system (QMS) in accordance with ISO 13485 and CDAKB.
- Conduct internal audits to ensure compliance with QMS procedures and regulatory requirements.
- Oversee the management of non-conformances, CAPA (Corrective and Preventive Actions), and continuous improvement initiatives.
- Ensure that all manufacturing processes are in compliance with quality standards and regulatory requirements.
- Develop and deliver training programs on quality and regulatory compliance for employees at all levels.
- Manage the process for supplier qualification and ongoing supplier audits to ensure quality and compliance of materials and components.
- Lead the preparation and coordination of external audits, including those conducted by regulatory bodies and notified bodies.
- Ensure that all product labeling, packaging, and promotional materials meet quality and regulatory standards.
- Oversee the documentation control process, ensuring that all documents are accurate, up-to-date, and properly maintained.
Regulatory Affairs:
- Develop and implement regulatory strategies to ensure compliance with local and international regulations for medical devices.
- Prepare, review, and submit regulatory documentation to health authorities, including product registrations, renewals, and variations.
- Conduct regulatory risk assessments and provide recommendations for risk mitigation.
- Ensure compliance with post-market surveillance requirements, including adverse event reporting and product recalls.
Qualifications:
- Bachelor's degree in a scientific or engineering discipline (e.g., Engineering, Pharmacist, or related field). A Master's degree is a plus.
- Minimum of 7 years of experience in regulatory affairs and quality assurance within the medical device industry.
- In-depth knowledge of local and international regulations for medical devices, including CDAKB, ISO 13485, and other relevant standards.
- Experience with product registrations and regulatory submissions in multiple regions.
- Strong understanding of quality management systems, including ISO 13485 and Good Manufacturing Practices (GMP).
