- Assist Regulatory Affairs Manager to coordinate and handle regulatory affairs in Singapore.
- Coordinate and manage timely Regulatory Submissions between local company and our overseas Manufacturers.
- Plan and execute all activities necessary for the product registration
- Maintain good communication with all manufacturing facilities to obtain support whenever required.
- Coordinate & implement registration procedure, personally write and review the application documents and submit dossiers for product registration.
- Maintain QMS (e.g. Good Distribution Practice for Medical Devices, GDPMDS) and implement any changes required including training and communications with affected parties.
- Negotiate with local authorities on behalf of Company objectives. Act as the key person to communicate and negotiate with local regulatory authorities.
- Keeping up with local regulatory requirements and inform relevant internal parties on a timely manner.
- Update our manufacturers for any changes in local regulatory requirement, help them to understand and work with them to provide strategy and multiple options for meeting those regulatory requirements.
- Handle product complain, reporting adverse events and recall to the local regulatory authorizes as required.
- Create training materials and train employees to improve regulatory skills in local office or region and at our manufacturers, where applicable
- Maintain QMS including provision of training to internal staff affected.
- Learn the Group vision for each regulatory submission and become a trusted leader in the organization
- Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements
- Degree in Science, Engineering or other related discipline.
- At least 3 years working experience in regulatory field for medical device or pharmaceutical industry would be an advantage, preferably in multinational companies.
- Experience in negotiating with regulatory authorities.
- Fluent in English (both spoken and written).
- Excellent communication and interpersonal skills, able to work with people from different levels internally and externally
- Excellent time management and organizational skills. Able to perform duties with limit supervision and meet deadline.
- Skilled in document management.
- High level of computer skills including Microsoft Office.
- Multi-tasks and able to prioritize the job tasks, depending on the urgency.
- Positive attitude, good team player and attention to details.
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