1 year contract Regulatory Affairs Specialist (medical Devices) - Up to $5K

Recruit Express Pte Ltd| Date Posted: 9-Jan-2021
EA Licence No: 99C4599|EA Personal Registration No: R1333338
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Job Nature:
Contract
Position Level:
Experienced, Manager
Qualification:
Bachelor's / Honours

Job Description

The Quality Assurance & Regulatory Affairs Specialist will be working proactively with the region’s Commercial and Business teams to ensure that optimal regulatory strategy meets required legislation in the specific countries, in an efficient and effective manner.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Regulatory Affairs:

  • Maintain the regional overview of country registration status and provide periodic status update as appropriate.
  • Assist in the development, review and implementing regional regulatory and quality processes/procedures based on corporate and regional requirements, to enhance cross-departmental activities.
  • Liaise with overseas affiliates and distributors pertaining to Regulatory Affairs activities, including compile and prepare regulatory documentation for submission to local authority, product registrations, variations to existing products, license renewals, etc.
  • Managing compliance of products in accordance with existing regulations and guidelines.
  • Update and maintaining all product registration license in the region and initiate renewal according to the country’s stipulated timeline.
  • Coordinate and provide assessment to market responses for information requests and change management assessment.
  • Keep abreast of regulatory change and trends to ensure compliance with local regulatory requirements and advise global RA teams on impact.
  • Support global and local initiatives and projects.
  • Participate as required in quality and regulatory training, seminars relating to area of work.

Education / Experience Required:

  • Diploma/Bachelor Degree in Biomedical/Pharmaceutical or equivalent.
  • Min 2-3 years of relevant working experience in QA/RA in medical device industry.
  • Able to start work immediately or short notice 

Salary range: Up to $5K

Medical Device MNC 

Interested candidates, please forward your resume to [Click Here to Email Your Resume] 

Consultant: Huang Jingsheng Kevyn (R1333338) 

Recruit Express Pte Ltd (99C4599) 

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