【BM】Senior Regulatory Affairs Specialist

職責

1. Plan, organize and implement regulatory strategies to for products in development and for modified products to achieve clearance/approval internationally (Taiwan, US, Japan, and Southeast Asia, etc.)
2. Prepare and review registration files for medical devices, such as 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. Provide regulatory input to product development teams, including products’ regulatory pathway and anticipated approval timelines.
5. Write and edit clinical development documents, including but not limited to, clinical protocols, investigators brochures, clinical study reports, clinical evaluation report, and master inform consent forms.
6. Provide support on clinical trial design consultation and execution, including communications with CRO’s and consultations with regulatory agencies.
7. Prepare and review registration documents for clinical trials of medical devices to ensure timely approvals by IRBs.
8. Assist in the QMS, ISO13485, QSR quality management system document control and participate and support audits by external bodies, including FDA, notified body, and other regulatory agency as needed.

工作需求條件

1. Minimum 3-year experience in regulatory affairs in the medical device industry.
2. Demonstrated solid knowledge of pre-market, quality management and clinical regulations, guidance, and procedures (QSR, ISO 13485, and GCP audits and inspections).
3. Demonstrated knowledge of global regulations / guidelines relating to AI/ML-based SaMD.
4. Demonstrated knowledge of clinical trial design is a plus.
5. Demonstrated knowledge of health technology assessment, public health, and epidemiology is a plus.
6. Demonstrated experience in interfacing with Notified Bodies to obtain approval is a plus.
7. Demonstrated experience in the preparation and submission of US, EU and Japan regulatory filings is a plus.
8. Target-oriented and self-driven with strong personal drive and excellent problem-solving skills are essential
9. Positive working attitude, can work under pressure and fast paced environment.

Required:
1. Education: Master's degree in a relevant field such as pharmacy, life sciences, medicine, biotech, healthcare, or a related discipline.
2. Experience: 3+ years
3. Skills: Technical report writing, Cross-functional team collaboration, Communication with external organizations or government

Preferred:
1. Experience in medical device regulatory affairs, medical device, Biomedical or related background and knowledge is preferred. 2. Be able to write technical documents in English and have good English email communication skills. 3. Strong technical writing, analytical thinking, problem solving and investigative skills are required.