Regulatory Affairs Specialist-Medical devices
jobsDB ref: JSG400003003033032
EA License No. 16C8340
Employer Ref. 33002002
Industry: HR/Staffing/Employment Agencies
Job Category/Function: Other Healthcare
Salary: SGD 4000 - 6000
Location: Central, Singapore
- About the client
- Our client is a renowned and most established Japanese Medical device manufacturing Company having its business across entire APAC region.
- They develop and handle sales of ultra-fine stainless steel wire ropes, PTCA Guide wires, Catheters etc. to be used in cardiac and other surgeries, terminal processed products etc.
- They are actively looking for a Regulatory Affairs Specialist to handle regional operations.
- To assess regulatory requirements and develop regulatory strategies for the qualifications of new products in Asean and Taiwan.
- Compile technical, clinical and production protocols and documentations necessary for regulatory submissions.
- Manage the regulatory submission process by coordinating closely with regulatory bodies, distributors and head office.
- 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.
- Degree in Biological Science/Pharmacy/Business Admin/Engineering or relevant discipline.
- Min. 3 years of regulatory experience in medical device, pharmaceutical or similar industry.
- Strong interpersonal, analytical and problem solving skills. Able to multi-task.
Interested applicants are invited to submit their resume via clicking the apply button.
Nijibox Co., Ltd Singapore Branch (EA No.: 16C8340)
Yata Hidetaka (Registration No.: R1216038 )
Regulatory compliance,medical devices,pharma
About Joint Recruiting
Joint Recruiting is a Singapore-based recruitment division of Nijibox Co., Ltd., a subsidiary of Recruit Holdings.
Established since 1963, Recruit Holdings is proud to be one of the HR industry leaders with an annual turnover of 13 billion in annual sales. Extending our holding company's strong foothold in the recruitment industry, Joint Recruiting was founded to help job seekers to get a right job fast through our proprietary technology innovation.