RAQA Specialist

S$35000 - S$45000 per annum
  1. Permanent
  2. Consultant / Specialist
  3. Korea, Republic of
서울, 대한민국
Posting date: 09 Jan 2024
58177

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.

Responsibilities:

  • 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 c.medrano@proclinical.com.sg

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.

#Regulatory

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