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Regulatory Affairs Specialist

3 weeks ago


Singapore Reeracoen Singapore Pte Ltd Full time

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