Regulatory Affairs Specialist
2 weeks ago
Job Title: Regulatory Affairs Specialist
Location: Tuas
Working Days: Mon -Fri
Working Hours: 7.45 AM-4.45 PM
**Salary**: Basic up to $4000
Job Duties
- Prepare and maintain the registry of all products registered locally and internationally.
- Prepare and maintain the market's regulatory requirements for implementation in the company.
- Follow-up on any pre-market information and data required for dossier submission to the market-authorized representative for new product registration.
- Assist in data collection from market authorized representatives for post-market surveillance.
- Update the relevant standards, regulatory guidelines, and essential requirements.
- Support in any product recall activities in the markets as required.
- Liaise with regulatory authorities on factory inspection and work on inspection preparation.
- Preparation of Post Market Surveillance, Declaration of Conformance, Essential Requirement, Vigilance, Adverse Event Reporting, MDR certification.
- Participate in the internal and external quality audits, and inspections.
- Work with sales and marketing, and QA on label requirements.
- Communicate any changes in market regulatory requirements to all relevant functions with an action plan and timeline for implementation.
Job Requirements
- Diploma/Degree in Life Science (Pharmacy, Biology, Chemistry, Pharmaceutical).
- In-depth knowledge of the cGMP, market regulations (HSA, FDA, TGA, CFDA, EU), and ISO 13485.
- Understanding of law, regulation, and pending regulation.
- Good communication, technical writing, and interpersonal skills.
WONG MENG KANG
Superform Consulting Pte Ltd
License No.: R1988500/15C7536
**Salary**: $3,500.00 - $4,000.00 per month
Schedule:
- Monday to Friday
Supplemental pay types:
- Yearly bonus
**Education**:
- Local Polytechnic Diploma (preferred)
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