Regulatory Affair Executive / Senior Executive
Hanalytics is looking for a Senior Executive or Executive to join our Regulatory Affair and Quality Assurance team. This position will play a crucial role in assisting our QA director to coordinate and handle regulatory affairs in Singapore and globally, coordinating and manage timely regulatory submissions to product registration authorities.
- Provide hospital in service and training of our appointed Sales Channels in the region with well documented training materials. Show and teach all users the ease of using our product Pre-Sales through on-site demo and Post Sales with hospitals users.
- Ensure all conferences / exhibitions are well organised according to our company standards. In charge of Product info updates and circulation to relevant staff and distributors through company log in website or emails.
- To gather, analyse data and business intelligence (competition) from various sources (internal and external) to develop a strategic road map for any GTM- go to market. To communicate the strategy to all relevant parties.
- New product kick off seminars for distributors and users to be organised at an appropriate time with the Sales department, with all relevant supporting marketing materials. Conduct professional product training with certification, having successfully attended the course.
- Work closely with our Machine Learning & Software development team when developing new products and engage in application sharing with them on market trends and wants.
- As the leader of future Product / Application Specialists (radiographers) in India, South Korea and Japan (we may need to add more specialists depending on our business growth), your leadership in this capacity is to ensure our strategies are efficiently and effectively implemented.
- 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.
Give it a shot by sending us your resume and expected salary here.
Shortlisted candidates will be notified within one week.