Regulatory Affairs Specialist

COMPANY OVERVIEW 
 
Our leading medical devices client who focuses on medical devices required for catheter treatment in Singapore is currently looking for suitable candidates for the Regulatory Affair Specialist role based in Singapore. 

JOB OVERVIEW

This position requires the individual to assist in obtaining and maintaining government approval for medical devices and any other related materials and to be able to prepare product dossier for pre-market registration.
 
JOB RESPONSIBILITIES 
 

• Responding to company policy and company requirements, propose strategic regulatory application and carry it out.
• Assess regulatory requirements and develop regulatory strategies for the qualifications of new products in ASEAN, Australia, and New Zealand.
• Compile technical files, test reports and documentations necessary for regulatory submissions.
• Maintain up to date documentation and archival regulatory submissions and related documents according to the company’s documentation policies and procedures.
• Maintenance of GDPMDS and ensure staff’s compliance to SOPs.
• Coordination with internal/external peoples for application/ query response document procurement.
• Coordination with other govt. authorities as and when required and instructed by upper rank personnel.
• Coordination with relevant peoples (Sales/Marketing, HQ-QA) and report to authorities if necessary
• Collect and compile regulatory information/updates and report to upper rank personnel and people involved.
• Managing schedules for regulatory submissions and adjust with understanding of importance of company policy and company requirements.

JOB REQUIREMENTS 
 

• Strong interpersonal, analytical, and problem-solving skills.
• Able to multi-task.
• Proficiency in Japanese language would be an advantage for communication with Japan Head office.
• Preference to have regulatory experience in medical devices.
• 3 or more years of experience in regulatory affairs for medical devices, pharmaceuticals, or cosmetics.
  
   

Interested applicants please send your resume to: 
Karan Tarani
Email: karan.tarani@jac-recruitment.com
EA Licence: 90C3026
EA Personnel No: R22107234


We regret to inform that only shortlisted candidates will be notified