Regulatory Affair Executive
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- Prepare and submit product registration documents and other relevant license application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration globally.
- Notify and update Health science Authority (HSA) and/or local country product registration of any change of particulars / documents related to product registration.
- Manage adverse event and field safety corrective action reporting to HSA and/or local country product registration within the stipulated timeline.
- Ensure changes to the approved products are timely submitted to HSA and/or local country product registration as required.
- Maintain product registration record and product registration database to ensure proper documentation and record filing.
- Maintain good communication with all manufacturing facilities to obtain support whenever required.
- Coordinate and 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 objective. Act as the key person to communicate and negotiate with local regulatory authorities.
- Keeping up with 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 authorities 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.
Qualifications and Experiences
- Degree in Science, Engineer or other related discipline or equivalent.
- At least 2 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.
- Medical Device Act and other medical device related regulations in Singapore and globally
- Skilled in document management.
- Fluent in English (both spoken and written)
- 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.
- 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 deadlines.