Recruit Express Pte Ltd

Regulatory Affairs Specialist (Medical Devices) - $3K to $4.7K

Recruit Express Pte Ltd | Date Posted: 8-Jul-2018
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

Product Registration (Local):
  • Prepare & submit product registration documentation & other relevant licences’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Singapore
  • Notify and update Health Science Authority (HSA) of any change of particulars / documents related to product registration
  • Manage adverse event and field safety corrective action reporting to HSA within the stipulated timeline
  • Ensure changes to the approved products are timely submitted to HSA as required
  • Maintain product approvals and dealer’s licences

Product Registration (Regional):
  • Assist APAC’s affiliates & business partners in data/information gathering from manufacturers, drafting/assisting in preparation of initial dossier for submission
  • Maintain product registration record and product registration database to ensure proper documentation and record filing for all affiliates and business partner countries



Job Requirements:

  • Min Diploma in Medical Science or equivalent
  • Min 1 to 2 years’ experience in regulatory affairs of medical devices 

Salary range: $3K to $4.7K 

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

Consultant: Huang Jingsheng Kevyn (R1333338) 

Company Overview
Recruit Express Pte Ltd
Singapore’s Largest & Most Preferred Recruitment Company! As a premier leading recruitment consultancy in Singapore, our success has been a result of our focus in facilitating the success of our Clients in business whilst enhancing the career opportunities for our Candidates. With our swift expansion across the region, we now have offices in Singapore, Taiwan, Sydney, Kuala Lumpur and Hongkong as well as a partner network in Shanghai and Japan. We serve with distinction and provide comprehensive staffing needs. As the total recruitment and staffing solutions partner, our goal is to provide our Clients the best staffing solutions through an integrated database network supported by localized content and services. EA Licence No.: 99C4599