Regulatory Affairs Manager

Job Responsibilities

1. Lead product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest.
3. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
4. Lead the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

Job Qualifications:

1. Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred.
2. A bachelor's degree with at least 5 years of relevant experience, others are welcome to apply.
3. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
4. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
5. You shall have complete registration experience of Class B, C and D medical devices.
6. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
7. Familiar with IVD product development and commercialization life cycle.
8. Systematically project management, good planning, execution and timely communication. Good presentation skills.
9. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
10. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.