Senior Regulatory Affairs Specialist

작업 내용

Job Description：

1. Plan, organize and implement regulatory strategies to expedite submissions with particular focus on the requirements in the US, EU, Taiwan, Japan, and Southeast Asia.

2. Prepare and review registration files for new medical AI software and / or software modification as required to ensure timely clearance or approvals.

3. Maintain regulatory submission timelines and track deliverables to ensure company goals are met.

4. Manage GMP documents in compliance with applicable regulations.

5. Participate and support audits by external bodies, including FDA, notified body, and other regulatory agency as needed.

6. Provide regulatory input to product development teams, including products’ regulatory pathway and anticipated approval timelines.

7. Provide support on clinical trial design, including communications with CRO’s and consultations with regulatory agencies.

Requirements：

1. Minimum 3-year experience in regulatory affairs / quality assurance in the medical device industry.

2. Demonstrated solid knowledge of regulatory affairs / quality assurance regulations, guidance, and procedures (QSR, ISO 13485, and GMP audits and inspections).

3. Demonstrated knowledge of global regulations / guidelines relating to SaMD.

4. Demonstrated knowledge of clinical trial design is a plus.

5. Demonstrated experience in interfacing with Notified Bodies to obtain approval is a plus.

6. Demonstrated experience in the preparation and submission of US, EU and Japan regulatory filings is a plus.

7. Familiar with EU MDR is a plus.

8. Familiar with Medical AI software and related regulatory requirements is a plus.

9. Target-oriented and self-driven with strong personal drive and excellent problem-solving skills are essential

10. Positive working attitude, can work under pressure and fast paced environment.