Senior/Regulatory Affairs Specialist

Location Singapore, Singapore
Job reference Exp-HCLS_1557898438
Salary AWS
Consultant name Alexis Bo Zhuang Mian
Consultant email alexis.bo@experis.com.sg
Consultant contact no. 65515307
EA License No. 02C3423
Consultant Registration No. R1872731

Responsibilities:

  • You will oversee the Singapore office's regulatory approval and product registration for medical device and cosmetics with the support of the local marketing teams.

  • You will work closely with the Malaysia and Vietnam office regulatory affairs counterpart for registration matters.

  • You will liaise with local regulatory authority as well as overseas partners pertaining to regulatory affairs, including product registrations, variations to existing products and renewals.

  • You will advise divisions on regulatory and guideline requirements pertaining to their respective products.

  • You will provide new product registration and license renewal progress updates on regular basis.

  • You will provide guidance and direction to relevant parties on local regulatory requirements for product label change, manufacturing change, facility change, product line extension, shelf life and changes to technical specification of devices.

Requirements

  • You will have at least a Diploma/Degree with a minimum 1 year of work experience in regulatory work in med device/pharma/biotech industry

  • You have excellent knowledge of local regulatory guidelines

  • You are meticulous and detail-orientated with good presentation and communication

Interested applicants please send your resume to alexis.bo@experis.com.sg

Bo Zhuang Mian

R1872731

Manpower Staffing Services (S) Pte Ltd

02C3423

Alexis, Zhuang Mian Bo EA License No.: 02C3423 Personnel Registration No.: R1872731