CooperVision Regulatory Administrative Assistant (12-months) in Kuala Lumpur, Malaysia

Job Summary:

The Regulatory Administrative Assistant provides support in carrying out regulatory operations ensuring tasks assigned are completed timely for SEA regulatory submission.

Essential Functions:

  • 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.

  • Others

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.

Work:

  • Light lifting and bending

  • Office environment.

  • Prolonged use of a computer

Education & Experience:

  • Experience in medical device regulatory submission desirable although not essential.

  • SPM level

Job: *Regulatory Affairs

Organization: *Regulatory Affairs

Title: Regulatory Administrative Assistant (12-months)

Location: Malaysia-Kuala Lumpur

Requisition ID: KUA0070