CooperVision Regulatory Administrative Assistant (12-months) in Kuala Lumpur, Malaysia
The Regulatory Administrative Assistant provides support in carrying out regulatory operations ensuring tasks assigned are completed timely for SEA regulatory submission.
- Support regulatory functions through preparation and compilation of all regulatory documents.
o Assist in the submission of new products registration to the health authority.
o Assist in the registration maintenance (change notification and renewal).
o Regular check on the regulatory submission status in the health authority official website.
o Filling of all related registration documents.
- Quality Assurance
o Support in compilation of all Standard Operating Procedures under Good Distribution Practice of Medical Device system.
o Assist on addressing product complaints from customer to manufacturer.
o Updating Global RAQA Database
o Any regulatory affairs related tasks and/or projects assigned.
Knowledge, Skills and Abilities:
Excellent attention to detail.
Excellent organization skills.
Excellent written and verbal communication skills in English and Bahasa Melayu.
Computer literate, with intermediate skill in the use of Word, Excel and Outlook.
Ability to work effectively either alone or as part of a team. Managing time effectively and completing tasks on time with general supervision.
Ability to read and understand technical material desirable although not essential.
Light lifting and bending
Prolonged use of a computer
Education & Experience:
Experience in medical device regulatory submission desirable although not essential.
Job: *Regulatory Affairs
Organization: *Regulatory Affairs
Title: Regulatory Administrative Assistant (12-months)
Location: Malaysia-Kuala Lumpur
Requisition ID: KUA0070