Perm Senior / Regulatory Affairs Specialist (Medical devices) - $3.8K to $5K

Recruit Express Pte Ltd| Date Posted: 16-Apr-2021
EA Licence No: 99C4599|EA Personal Registration No: R1333338
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Job Nature:
Permanent
Position Level:
Experienced, Manager
Qualification:
Diploma, Bachelor's / Honours

Job Description

  • Evaluate regulatory risks of Medical Business division policies, processes, procedures
  • Develop new regulatory policies, processes and SOPs in Medical Business and train key personnel
  • Prepare and maintain technical documentation packages to ensure regulatory requirements for product registration submissions to competent authorities are met in regional countries
  • Update, renew and maintain document control system, including registration documents, files, records of new and existing product portfolio
  • Monitor impact of changing regulations and update internal stakeholders
  • Oversee processes involved with maintaining annual licenses, registrations, listings and import/export controls
  • Review and approve advertising and promotional items to ensure regulatory compliance and ensure external communications meet regulations in Medical Business
  • Provide regulatory input for product recalls and recall communications
  • Coordinate and implement quality system standards required
  • Responsible for proper documentation of internal and external audits
  • Assist management in the implementation and maintaining of regulatory system; legal and compliance issues pertaining to quality management system
  • Compile all regulatory data and framework to educate relevant / related stakeholders

Education / Experience Required:

  • Min BS degree in any courses 
  • Minimum 2 to 3 years of regulatory affairs experience in medical devices 

Salary range: $3.8K 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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