|Location:||New York, NY|
|Language:||English: Business Level, Japanese: Native Level|
Japanese company seeks a Regulatory Affairs Associate.
This is temporary position.
This is a Japanese and English bilingual position(Read, Write, Speak) .
(a) Project Planning and Management
• Plans executes and m anage s regulatory project s of medical device registration process (including
FDA and OUS by communicating with project members (external regulatory c onsultant s and
colleagues in the US and Japan).
• C ommunicates with the project members and respond s to requests or questions from them
• Coordinates meetings (including virtual and in person) as necessary and make a minute
• Controls the project progress to meet the predetermined due dates
(b) Document Preparation and Review
• Gathers information and prepares documents to be submitted to FDA or authorities OUS
• Reviews and edits documents prepared by external regulatory consultants.
• Reviews and edits English documents translated from original Japanese documents.
(c) Compliance Document ation
• Maintains compliance documents, including SOPs and records for business activities, to comply with
US laws and regulations, including Medical Devise Reporting (MDR), Quality System Regulation
(QSR), Physician Payment Sunshine Act, Anti Kickback Statute and others as necessary
Hours: 3-5days/week, and 3-4hrs/day (Flexible)
Location: Manhattan, NY, Hybrid (WFH and Office)
Salary: $22-$30/hr (DOE)
*This is temporary position.(temporary period is TBD.)