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Regulatory Affairs Specialist
3 weeks ago
Our client is Medical medical devices company and now they are looking for Regulatory Affairs Specialist.
You will be reporting to Regulatory Affairs Manager
【 What you will be doing 】
- Responding to company policy and company requirements, propose strategic regulatory
- 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.
procurement.
- Coordination with the other govt. authorities as and when required and instructed by
upper rank personnel.
- Post-marketing activities
- Coordination with the relevant peoples (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.
- Schedule management
- Manage schedules for regulatory submissions and make adjustments with
understanding of importance of company policy and company requirements.
- Regarding schedule change, report upper rank personnel and people involved in timely
manner.
- Industrial activity
- Participate industrial activities and negotiate with authorities.
- Others
- Follow your supervisor’s instructions.
- ** Requirement**:
- 【 What they are looking for 】
- Education and/or experience in medical devices or a related field.
- Experience in product, business processes/procedures, regulatory frameworks and requirements.
- Experience in medical devices is highly preferable
- ** Working Hour**: 8:30 ~ 17:30
- ** Benefit**:
- 【 What they are offering 】
- AWS
- 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