Our client is seeking a Regulatory Affairs/Quality Assurance (RA/QA) Manager to join their team in Taipei. This role is primarily focused on regulatory affairs for medical devices, with responsibilities extending to quality assurance and people management. This is an exciting opportunity to work in a dynamic environment where your skills and experience will be highly valued.
What you'll do:
As the RA/QA Manager, you will play a pivotal role in ensuring our client's products meet all necessary regulatory requirements. Your excellent organisational skills will be utilised as you compile and submit new product registrations, while your keen eye for detail will be essential in monitoring changes to regulations and policies. You'll also have the opportunity to demonstrate your leadership abilities as you manage the RA/QA specialist team. This role offers a unique blend of regulatory affairs, quality assurance, and people management responsibilities.
- Compile and submit new product registrations, QSD registrations, license extensions, changes, and renewal according to the submission plan.
- Submit reports as required by HQs.
- Lead the Taiwan team in complying with Taiwan medical device regulations.
- Monitor changes to regulations and policies and proactively identify issues that may have a business impact.
- Attend industry’s committee meetings, gather information and draft proposals to government/authorities.
- Manage IFU and labels for imported products.
- Provide training to branch members.
- Support the product complaints handling, quality field actions, recalls and PMS data collection or reporting in Taiwan.
What you bring:
As an ideal candidate for the RA/QA Manager position, you bring a wealth of experience in regulatory affairs for medical devices. Your knowledge of Taiwan's medical device regulations is second-to-none, enabling you to lead our client's Taiwan team effectively. Your ability to monitor changes to regulations and policies ensures that potential business impacts are identified early. Your experience in managing IFU and labels for imported products is invaluable, as is your ability to provide training to branch members. Lastly, your experience in supporting product complaints handling, quality field actions, recalls and PMS data collection or reporting makes you an asset to any team.
- Experience in regulatory affairs for medical devices.
- Knowledge of Taiwan medical device regulations.
- Ability to monitor changes to regulations and policies.
- Experience in managing IFU and labels for imported products.
- Ability to provide training to branch members.
- Experience in supporting product complaints handling, quality field actions, recalls and PMS data collection or reporting.
What sets this company apart:
Our client is a leading player in the medical devices industry. They are known for their commitment to innovation, quality, and patient safety. Their products are used by healthcare professionals worldwide, making a real difference in patients' lives. This is an opportunity to join a company that values its employees and offers a supportive and collaborative work environment.
What's next:
If you're ready to take your career to the next level with a role that offers variety, challenge, and the opportunity to make a real impact, don't hesitate!
