- Regulatory support and registration of the company product at various countries.
- Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
- Responsible of establishing and maintenance of technical files.
- Establishment, maintenance and management of QA system and document control per internal and external regulatory requirements.
- Responsible for company’s product quality and reliability to meet or exceed customer expectations
- Responsible for company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards worldwide.
- Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities.
- In support of the quality system, provide effective leadership support, training and guidance to all company personnel.
- Responsible for writing/guiding employees for writing all company procedures, specifications, instructions etc.
- Responsible for internal and external audits system.
- Responsible for approval of finished product release.
- Relevant education (BSc in related field and quality related education).
- Previous experience in the medical devices or life science regulatory managements.
- Previous experience in QA and RA of medical devices companies
- Experience in drafting, submitting and maintaining regulatory related files (510k, technical file, etc.)
- Experience in leading the preparation and presentation of external audits.