8 Months Contract Medical Device Regulatory Affair Specialist (US MNC) #HJC - #1090917

• Prepare and complete product registration tasks covering the new product registration, the registration amendment, and the renewal registration. Ensure product tests/samples meet safety and performance requirements of regulatory agencies in collaboration with lab technicians
• Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission.
• Create local language labels and Instruction For Use in compliance of country regulations before passing them to Supply Chain
• Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations etc.
• Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
• Serve as regulatory liaison throughout product lifecycle. Participates in regulatory strategy and operating plans.
• Handle product recall reporting to regulatory agencies, for products exhibiting non- compliance
• Review marketing advertisements to ensure compliance to regulations and submit to FDA for approval

Job Requirement:

• Degree in Biomedical/Material Science or relevant discipline.
• Minimum 3 years of experiences in RA work, particularly in medical devices
• Able to start from 2 May onwards

 TELE me at @jacechooo or WA me at https://wa.me/+6582976283 NOW!

Interested candidates please submit your resume to [email protected]

Jace Choo Oi Kei

Personnel EA License No.: R1875164

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