Proclinical are recruiting for a RAQA Specialist to join a medical technology and devices organisation. This role is on a permanent basis and is located in South Korea.
- Responsible for registration dossier request for the necessary products.
- You will prepare the applications for approval on the test samples.
- Discuss with MFDS, testing lab and the company for additionally necessary information.
- Manage the periodic renewal of KGMP certificates which involves manufacturing site inspection.
- Collate KGMP certificates for new manufacturing site and new product category of current manufacturing sites.
- Accountable for gap analysis of current licenses and recognising the need of license update and/or renewal which may be linked to product changes, Korean regulation changes, license expiry, etc.
- The ideal candidate will follow-up on tasks, for example: DMF, Korean labelling updates, System upload.
- Responsible for preparing product labelling in Korean after the registration is accomplished.
- Assist the RA/QA director for ISO 13485 certificates & quality system.
- Handle staff training on quality system.
- Assist RA/QA director with recall arrangement and report recalls, safety information to MFDS, etc.
- Accountable for special projects allocated / UDI database support.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a biomedical engineering field would be ideal.
- Demonstrable work experience in a pertinent role.
- Interpersonal and communication skills both verbally and in writing.
- An organised individual with deliberation skills.
- Fluency in the English language.
- Computer literacy.
- Expertise on anatomy, chemical/physical properties would be advantageous.
If you are having difficulty in applying or if you have any questions, please contact Cherry Medrano at email@example.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.