Job Description

6 months contract(Convertible to Perm)

Responsibilities:

• Responsible for regulatory activities in SE Asia: regulatory submissions, compliance for new or existing products

• Manage registration plans for new products, variations, modifications, registration renewals

• Analyse registration complexity and provide regulatory advice to internal and GC groups 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 or changes

• Provide post market regulatory support and guidance as required

• Follow up on product license renewal

• Any other ad-hoc duties as assigned
  

• Degree / Diploma in Life Sciences, Engineering, or related discipline

• At least 5 year of related working experience, preferably in the medical device /pharmaceutical / life sciences industry

• Possess good 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)

• Knowledge and specialization in Regulatory and Quality Affairs (Quality Control/Assurance) is an advantage

• Excellent communication skills and English at work proficiency level (writing and conversational)

• Proficient in Microsoft Office

• Independent, meticulous, detail-oriented, and proactive

• Ability to Multi-task & Proactive

• Positive working attitude with passion to learn and develop

• Able to adapt in a fast-paced environment