RAQA Specialist job in 서울, 대한민국

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Consultant / Specialist

Location: Korea, Republic of

This vacancy has now expired. Please see similar roles below...

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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