Regulatory Affairs, Senior Executive ($3.8K to $4.2K) - Scientific Devices

Recruit Express Pte Ltd| Date Posted: 28-Jun-2019
EA Licence No: 99C4599|EA Personal Registration No: R1333338
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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Diploma, Bachelor's / Honours

Job Description

  • Participate in the development and lifecycle management of products to ensure compliance with all internal and external requirements for markets such as EU, US, Japan, Korea and APAC.
  • Develop, implement and maintain regulatory strategies and regulatory submission plans in order to meet project milestones.
  • Prepare, update and maintain technical files/submission dossiers as per applicable SOPs, and liaise with the relevant departments as required.
  • Work with project teams to resolve complex project issues by strategically interpreting and clearly communicating regulatory requirements.
  • Review and approve documents such as Engineering Change Orders, Design Change Notices and validation reports for scientific merit and regulatory appropriateness for compliance with international regulations and standards.
  • Ensure labelling meets all relevant international requirements.
  • Conduct regulatory assessments for change controls in line with international regulatory requirements.
  • Support internal and external audits as required.
  • Contribute to the review and improvement of regulatory processes.

Requirements:

  • Min Bachelor’s Degree in science or engineering or any other courses 
  • Min 2 to 3 years of working experience in Regulatory Affairs field
  • Knowledge of Medical and/or Industrial Scientific Device regulations

Salary range: $4K to $5K 

MNC (Scientific Devices) 

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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