Regulatory Affairs Executive
1 month ago
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
Tell employers what skills you have
FDA
Quality Management
Quality Assurance
Regulatory Affairs
Oncology
ISO
Problem Solving
Packaging
Audits
Change Control
Medical Device Directive
Regulatory Requirements
Africa
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