Regulatory Affairs Manager

AIBEDA is a Management Consulting Firm dedicated to medical devices and digital healthcare technology. With a combined 100 years plus of experience in the medical and technology fields, AIBEDA is able to offer specialty services for product development lifecycle management ranging from strategic planning, regulatory and clinical strategies to commercialization. AIBEDA is seeking a highly motivated industry expertise in responsible regulatory affairs in a fast-paced healthcare environment.

As part of the team, your participation will contribute to the success of AIBEDA's clients' innovations. If you are passionate about science and excited to learn about healthcare and medtech breakthroughs' impact on people, we want to hear from you.

[Responsibilities]
• Design regulatory strategy and lead cross-functional meetings
• Independently manage the registration of new products to become marketed products and ensure regulatory approvals are achieved in accordance with the client’s objectives
• Support regulatory inspection-readiness for the client, including leading or participating in internal and external regulatory audits
• Work with the Clinical Operations team to plan market-driven clinical studies


[Requirements]
• Graduate or advanced degree majors in biology, pharmaceutical science, biomedical engineering, public health, or related disciplines.
• At least 3 years of quality or regulatory affairs experience in diagnostics, medical devices, or healthcare industry. Familiarity with FDA or CE is a plus.
• Fluent oral and written communication skills in both English and Mandarin
• Good interpersonal skills
• Highly self-motivated and willing to learn
• Desire to join a fast-paced, high-growth organization with tremendous opportunity for future advancement