Regulatory Affairs Manager, SEA

Emplacement: 
Singapore
Type d'annonce: 
Permanent
Réf: 
BBBH741293
Salary: 
Competitive
Consultant: 
Anne Lim - R1104777
EA Licence No: 
11C5502
MOM Registration: 
R1104777

Regulatory Affairs Manager, SEA

  • Responsible for regulatory activities in SE Asia: regulatory submissions, compliance for new/ existing products
  • Manage registration plans for new products, variations, modifications, registration renewals
  • Analyse registration complexity and provide regulatory advice to internal and the business group to support company's business objectives
  • Collect and analyse regulatory intelligence, and incorporate regulatory trends into decision-making processes
  • Approval of product labelling with local regulations
  • Maintain awareness of regulatory requirements/ changes
  • Provide post market regulatory support and guidance as required
  • Follow up on product license renewal
  • Any other ad-hoc duties as assigned

Requirements:

  • Degree in life science or engineering
  • At least 5 years of work experience in medical device / pharmaceutical / life science industry
  • Possess relevant work experience and knowledge of regulations and requirements for medical devices, GDPMDS (Good Distribution Practice for Medical Devices), EU Medical Device Directive / Regulation, US FDA guidance, ISO standards (13485, 9001)
  • Proficient in Microsoft Office
  • Meticulous and detail-oriented
  • Able to work independently and adapt in a fast-paced environment
  • Excellent communication skills and English at work proficiency level (writing/conversation)

If you are keen for the above role, do send in your updated CV to annelim@morganmckinley.com.sg. Shortlisted candidates will be notified and arranged for a confidential chat.

Morgan McKinley Pte Ltd
EA Licence No: 11C5502
Registration No: R1104777

Anne Lim - R1104777's picture
Anne Lim
Senior Consultant | Sales & Marketing Recruitment
+65 6818 3157
annelim@morganmckinley.com.sg