The RA/QA Supervisor shall lead Regulatory Affairs and Quality Assurance activities for Vietnam market such as, but not limited to:
- Watch over regulatory aspects for product portfolio manufactured and distributed under KARL STORZ brand name.
- Perform specialized level work assignments and preparation, submission of documentation for medical device registration of KARL STORZ's products.
- Interact with multiple departments within KARL STORZ Group worldwide as well as relevant authorities of Vietnamese government to support necessary regulatory activities required for product market entry, business-related and maintenance in Vietnam.
Your Mission
- Prepare dossiers and submit for new registration/renewal/ variation of medical device products manufactured/distributed under KARL STORZ brand name with Ministry of Health and Department of Health; ensure the compatibility of submitted dossier with the current guidelines in Vietnam.
- Follow up the applications and keep contact with authorities for updates and giving feedback if any. Ensure the proposed timeline to obtain the marketing authorization of KARL STORZ products in Vietnam.
- Support related departments on importation process of medical devices relating to RA aspects: provide product licenses/market circulation number, internal standard, regulation; compile letter to authorities relating to RA when required.
- Always stay updated, share information, report and communication on legislation/new regulations related to medical device and its business under the regulatory responsibility with other departments.
- Coordinate well with Marketing/ Technical/R&D Departments to collect information for registration of KARL STORZ products portfolio.
- Support on preparing labels and additional content to fulfill application requirements from Vietnamese authorities by coordinating with other departments and KARL STORZ Global, etc. Ensure the compliance of labels/catalogs/IFU content and registered information in Vietnam.
- Any other assignments or duties that may arise out of changes in organizational business, process, structure, etc.
This description of responsibility is not concluding and therefore can be changed or amended at any time.
Your Talents
- Minimum 3-5 years of relevant experience in medical devices RA/QA functions
- University graduation with major in Engineering/Technical/Pharmaceutical/Medical or equivalent degree is a must.
- Possession of Certificate for classification of medical equipment is a plus.
- Good knowledge and understanding of medical devices regulatory affairs and quality assurance and relevant standards.
- Proficient English skills
- Be creative, well-organized, motivated and problem-solving skills.
- Ability to take initiative.
- Leadership
- Able to perform communication well, teamwork, cross-functional collaboration.
- Able to assist in creating and maintaining a harmonious and excellent work environment for fellow colleagues to work in.
