Regulatory Affairs Specialist
Kang Shi Fu Beverage Singapore Jurong East Full-time
Job Summary
We are seeking a detail-oriented and results-driven Regulatory Specialist to join our team. You will play a crucial role in ensuring our success by safeguarding product quality and safety through strict adherence to regulations. The ideal candidate will have a strong understanding of relevant regulations and a passion for compliance.
Responsibilities- Prepare and submit regulatory documentation to government agencies
- Manage regulatory projects, ensuring accurate and timely preparation and submission of documentation
- Stay updated on regulatory changes, conduct ongoing research, and inform the team of updates that may impact products
- Develop and implement regulatory strategies to ensure compliance with applicable laws
- Prepare and submit post-market surveillance reports
- Conduct risk assessments and identify potential compliance issues
- Maintain and manage regulatory documentation and records
- Represent the company in interactions with regulatory agencies, as needed
- Diploma in Food Science, Chemistry, Microbiology, Nutrition, Law, or related field
- At least 1 year of experience in regulatory affairs or quality (fresh graduates welcome)
- Excellent written and verbal communication skills
- Strong attention to detail and analytical skills
- Ability to work independently and collaboratively within a team
- Able to communicate and write in Chinese
- Only Singaporeans may apply
Recruit ExpressBedok, 21 km from Jurong East
or related field
• Min. 4 years regulatory affairs experience in medical devices
• Hands-on experience with US FDA submissions is required
• Familiar with ISO 13485 and medical device regulations
Interested applicants, please send your updated resume...
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