[Medical Devices] Regulatory Affairs Specialist.

Jobinhalt

Job Description

Johnson & Johnson Medical Taiwan Ltd. is recruiting for a RA Specialist, located in Taipei. Regulatory Affairs Specialist assist in obtaining and maintain TFDA approval for medical devices and its related QSD site registration licenses to support JJMT operation.

Key Responsibilities

• Conduct new product registration as well as life management of existing products.
• Obtain & renew QSD/GMP certificates to ensure the validity.
• Follow up the registration document with sourcing group, and the TFDA reviewer to expedite the registration approval process to meet BU planned schedule.
• Collaborate with relevant functions to update regulatory status and issues to mitigate risks.
• Ensure the accuracy of RA license management database by regular checking.
• Archiving the registration documents systematically & ensuring the accessibility of these documents.
• Familiar with local regulations related to medical devices & fully compliance to it.
• Conduct regular meeting with sourcing RA, BU, Marketing to update regulatory status to achieve planned timeline.
• Project assignment from the line manager.

Education

Qualifications

• Education Level: University Degree or above
• Field of Study: Life Science, Medical Technology, Engineering, Business Management

Required

• At least 1 - 2 years’ experience in managing RA business in Medical Device or Pharmaceutical product
• Computer skills in using MS Word/Outlook/Excel/PowerPoint

Preferred

• At least 3 - 5 years’ experience in managing RA business in Medical Device or Pharmaceutical product

Other

• Fluent in both verbal & written English
• Taiwan product Registration & License Maintenance Guideline
• Guidance of Copy Review & Approval
• Maintenance of License Management System
• Pharmaceutical Affairs Act/ New Medical Device Act
• Registration guidance for medical device

Qualifications

see above

Primary Location
Taiwan-Taipei-Taipei-
Organization
Johnson & Johnson Medical Taiwan Ltd. (8582)
Job Function
Regulatory Affairs
Requisition ID
2105929159W