Job Description
Our Client:
Our client is one of the top leading Medical Device companies, headquartered in Japan. They're actively looking to hire a Regulatory Affairs Specialist to join their team in Singapore.
The Responsibilities:
* Responding to company policy and company requirements, propose strategic regulatory application and carry it out
* Assess regulatory requirements and discuss regulatory strategies with the related staff for the qualifications of new products in Asia Pacific (ASEAN, Australia, and New Zealand)
* Compile technical files, test reports and documentations necessary for regulatory submissions in the above countries
* Maintain up to date documentation and archival regulatory submissions and related documents according to the company's documentation policies and procedures
* Maintenance of medical device related licenses and ensure staff's compliance to SOPs
* Coordination with internal/external peoples for application/ query response document procurement
* Coordination with the other govt. authorities as and when required and instructed by upper rank personnel
* Support RA/QA activities for the above countries based on instructions from upper rank personnel
* Collect and compile regulatory information/updates and report to upper rank personnel and people involved
* Manage schedules for regulatory submissions and adjust with understanding of importance of company policy and company requirements
* Regarding schedule change, report upper rank personnel and people involved in timely manner
The Requirements:
* Min 3 years' experience in regulatory affairs in the healthcare industry
Disclaimer: The Company complies with the Tripartite Guidelines on Fair Employment Practices (TGFEP), including the prevailing guidelines on recruitment. All qualified applicants will be considered for the position regardless of their age, race, religion, nationality, marital status, or family responsibilities. A more detailed discussion of the TGFEP is available on the Tripartite Alliance for Fair and Progressive Employment Practices (TAFEP) website at https://www.tal.sg/tafep.