Regulatory Affairs, Medical Devices ($3.5K to $5K)

Recruit Express Pte Ltd| Date Posted: 4-Jun-2019
EA Licence No: 99C4599|EA Personal Registration No: R1333338
Save Job
Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Diploma, Bachelor's / Honours

Job Description

  • Evaluate regulatory risks of  policies, processes, procedures
  • Develop new regulatory policies, processes and SOPs in Business and train key personnel on them
  • Compile, prepare, review and submit regulatory submission to authorities
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders
  • Oversee processes involved with maintaining annual licenses, registrations, listings and patent information
  • Ensure compliance with product marketing approval requirements
  • Review and approve advertising and promotional items to ensure regulatory compliance and ensure external communications meet regulations in  Business
  • Provide regulatory input for product recalls and recall communications
  • Responsible for the preparation of documents for internal and external audits
  • Assist management in the monitoring of implementation of the regulatory system; legal and compliance issues.
  • Compile all regulatory data and framework to educate relevant / related stakeholders
  • Distributor Agreements Management, including timely renewal.
  • Coordinate and implement ISO system and standards required

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 in Medical devices industry 
  • Understanding GDPMDS and ISO13485 will be advantageous ; 

Salary range: $3.5K to $5K 

US MNC (Medical Devices) 

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

Consultant: Huang Jingsheng Kevyn (R1333338) 

Company Overview
Recruit Express Pte Ltd