Responsibilities:
- Prepare product technical dossiers for regulatory submission
- Understand labelling requirements in multiple region and manage artwork used in product packaging
- Liaise with relevant parties to resolve product registration and regulatory issues
- Maintain document control of technical file, quality procedures and work instructions for the purpose of product registration and to support audits
- Ensure that all required tests and documentation for product variation/ new product activity are promptly performed
- Keep track of changes in country regulatory requirements and provide regulatory intelligence and support to top management / relevant departments / subsidiaries.
- Implement regulatory strategies to optimize development and registration of new and marketed products
- Maintain and improve Quality Management System to comply to comply with ISO 13485 as well as international regulatory requirements (eg: EU Medical Device Directive / Regulation, MDSAP, US FDA QSR 820 standards, etc), including involvement in external and internal audits
- Any other ad-hoc projects or duties as assigned
Requirements:
- Diploma/degree in Engineering, Science or equivalent
- 1 years of relevant working experience in Quality Assurance / Regulatory Affairs in structured medical device environments
- Good knowledge in ISO 13485, EU Medical Device Directive / Regulation, MDSAP and US FDA QSR 820 standards
- Proficiency in MS Office applications
- Good problem solving, interpersonal, written and verbal communication skills
- Pro-active team player, mature, resourceful, meticulous, analytical and able to work independently
