- Salary: Undisclosed
- Work Type: Permanent / Full Time
- Min. Education Level: Diploma
- Field of Study: Bioengineering
- Years of Experience: 1
- Skills: Regulatory
Jnr Regulatory Affairs Engineer
- To assist in preparing, compiling and maintaining all necessary and required product registration documentation. Including coordinating registration related activities, sample preparation ans selection, sample testing, investigation of testing failure and ect.
- To coordinate Regulatory Change with relevant competent authorities including preparing compiling necessary documentation for submission.
- To assist in update and maintaining product registration profile.
- To assist in implementing adverse event reporting and product recall including preparing, monitoring and follow-up with relevent competent authorities.
- To assist in preparing, compiling and maintaining all necessary and required ducumentation for Trademark Registration.
- To assist in monitoring ducument control operation related activities(including Quality Management System documentation, artworks and barcodes) and ensuring relevant activities are compliance with ISO 9001, ISO13485, CE Marking, US FDA 21 CFR Part 820 QSR and any other statutory and regulatory requirements.
- To assist in updating new published and revised National and International Standards in library for users reference.
- To provide in-house training related to company Document Control procedures.
- Any other tasks assigned by supervisor.
- Candidate must posses at least a Diploma/Degree in Quality Management or Biomedical Engineering or other related fields.
- At least with 1-2 years working experience in Quality Management System and/or in the filed of Regulatory Affairs in Medical Devices.
- Knowledge of ISO 9001, 13485, MDD 93/42/EEC, US FDA 21 CFR Part 820 QSR, HSA and/or other country product registration regulations.
- Ability to converse, write and read well in English and Mandarin.
- Able to work independently and proactive.