Regulatory Affairs Specialist, Regional
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Serves as the core-team member for regulatory affairs functions.
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advice on the submission strategy for NPD Projects and existing products in countries.
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners.
- Review labelling and labels for compliance with regulatory requirements for NPD and projects as assigned.
- Review changes to existing products and SOPs to define the requirements for regulatory submissions.
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.
- . Oversee and maintain vigilance on regulatory issues and disseminate regulatory information to relevant departments and management as required.
- Help to ensure compliance of the site to the Quality Management System.
- Conduct or support internal audits and Quality Management Review. Provide Regulatory Affairs support for external audits and inspections.
- Ensure good clinical research support and review advertisement and promotional literature.
- Support training to ensure proper implementation and use of procedures as required.
QUALIFICATIONS AND EXPERIENCE
- B.S. Degree in Science and Engineering field with at least 1 - 3 years relevant experience within the regulatory affairs discipline
- Working knowledge international medical device regulatory requirements
- Excellent analytical decision making and problem solving skills
- Good written and verbal communication skills
Only shortlisted candidates will be notified via email.
If you meet the essential requirements for this position, please send your latest CV through the link provided , or call Vanessa Tan at +65 6871 4700 for further information.
Registration no: R1873695
EA Licence no: 16S8216
Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
Award winner of:
International Recruitment Company of the Year by Recruitment International 2016
Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016
Best Overseas Operation by Global Recruiters 2017
Highly Commended for Best Large Recruitment Business 2017