Regulatory Affairs SpecialistID:100467903,500 SGD ~ 5,000 SGDCentral, North
Medical & Healthcare > Others (Medical & Healthcare)
Logistic > Purchase/Procurement,Logistic Coordinator/Executive
Business Administration > General Affairs/Administration,Sales Coordinator
Healthcare & Medical
Our client is a Medical Devices company and is now looking for a Regulatory Affairs Specialist.
You will be reporting to Regulatory Affairs Manager
【 What you will be doing 】
■Regulatory application, Compliance
- Responding to company policy and company requirements, proposing strategic regulatory application and carrying 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 documentation 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 ensuring staff’s compliance with SOPs.
- Coordination with internal/external people for application/ query response document procurement.
- Coordination with the other govt. authorities as and when required and instructed by Upper-rank personnel.
- Coordination with the relevant people (Sales/Marketing, HQ-QA) and report to authorities if necessary.
■Collection of Regulatory information
- Collect and compile regulatory information/updates and report to upper-rank personnel and people involved.
- Manage schedules for regulatory submissions and make adjustments with understanding of the importance of company policy and company requirements.
- Regarding schedule change, report upper-rank personnel and people involved in timely manner.
- Participate in industrial activities and negotiate with authorities.
- Follow your supervisor’s instructions.
【 What they are looking for 】
- Relevant education or working experience in medical devices or a related field.
- More than 3 years of regulatory application experience in the field of medical devices.
- Experience in the product, business processes/procedures, regulatory frameworks and requirements.
8:30 ~ 17:30
【 What they are offering 】
- Variable Bonus (Depends on the Company and Individual Performance)
- Annual Leave 14 days (Max 21 days)
- Medical Insurance Include Dental
- Dental Allowance S$150/year
- Medical Allowance S$600/year