Our client is seeking a dedicated and knowledgeable Regulatory Affairs/Quality Assurance Specialist to join their team in Taipei. This role offers an exciting opportunity to work on regulatory affairs, primarily for medical devices, and quality assurance. You will be responsible for compiling and submitting new product registrations, managing IFU and labels for imported products, providing training to branch members, and supporting the maintenance of UDI information.
What you'll do:
As a Regulatory Affairs/Quality Assurance Specialist, your role will be multifaceted. You will be at the forefront of ensuring that our client's medical devices meet all necessary regulatory requirements. Your excellent organisational skills will be put to use as you compile and submit new product registrations while working closely with the HQ/manufacturer site. Your keen eye for detail will be essential as you review promotional materials for compliance with regulations. In addition to these responsibilities, you will also play a crucial role in quality assurance. From collecting quality information to supporting product complaint handling, your contributions will ensure the highest standards of quality are maintained.
- Compile and submit new product registrations, license extensions, changes, and renewals according to the submission plan.
- Work collaboratively with HQ/manufacturer site.
- Submit reports as required by HQs.
- Attend industry’s committee meetings, gather information and report to company.
- Manage IFU and labels for imported products.
- Provide training to branch members.
- Take measurements for pharmaceutical related when necessary.
- Apply for reimbursement applications.
- Review and apply promotion and advertising material for compliance with applicable regulations.
- Support to maintain the UDI information to TFDA TUDID.
- Collect quality information, report and provide feedback.
- Collect information of relevant laws and regulations, and take necessary actions.
- Support the product complaints handling, quality field actions, recalls and PMS data collection or reporting in Taiwan.
What you bring:
As a Regulatory Affairs/Quality Assurance Specialist, you bring a wealth of experience and knowledge to the table. Your background in healthcare, specifically with medical devices, makes you an ideal candidate for this role. Your understanding of regulatory affairs will be instrumental in ensuring that all products meet the necessary guidelines and regulations. Your strong organisational skills will enable you to manage multiple tasks simultaneously, while your excellent communication skills will foster effective collaboration with various teams. Additionally, your experience in handling product complaints and developing Quality System policies will be invaluable in maintaining the highest standards of quality.
- Proven experience in Regulatory Affairs and Quality Assurance within the healthcare industry.
- Strong knowledge of medical device regulations and guidelines.
- Excellent organisational skills with an ability to manage multiple tasks simultaneously.
- Strong communication skills with an ability to work collaboratively with various teams.
- Experience in providing training to team members.
- Understanding of UDI information maintenance procedures.
- Ability to handle product complaints effectively.
- Knowledge of Quality System policies and experience in developing them.
What sets this company apart:
Our client is a leading player in the healthcare industry, known for their commitment to innovation and quality. They offer a supportive work environment where every team member's contribution is valued. Their focus on continuous learning and development ensures that their employees are always at the forefront of industry advancements. This is an excellent opportunity to join a company that truly values its employees and offers numerous opportunities for growth and advancement.
What's next:
If you're ready to take your career to the next level with a challenging and rewarding role, don't hesitate!
Apply today by clicking on the link!
