1) To assist in registration/approval for the medical devices in different countries.2) Maintain internal and source company databases of regulatory approvals3) Preparation of dossiers and on-time submissions to the local health authority in accordance with Marketing launch plans and global timelines.4) To ensure understanding of regulatory requirements and request the documentation required for registration submissions5) Liaise with regulatory authorities and designated agents on all registration matters including to the Malaysian medical device regulatory requirements.7) Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio8) Keep internal team members updated with the complying medical devices regulatory news and update, guidelines and etc.9) Facilitate/ track the preparation and submissions of regulatory documents, registration dossiers, licenses for manufacturing facility, etc. to support the projects.10) To support all EU MDR related matters-main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745.11) Act as the Person Responsible for Regulatory Compliance (PRRC) in respect of the EU MDR issues.12) Act as Internal Auditor during internal audits for complying regulation.13) Any other tasks as assigned by the reporting superiorQUALIFICATION AND EXPERIENCE1) At least a Bachelor degree or equivalent.2) At least 1 year of working experience in related field.3) Knowledge of ISO 9001 and ISO 13485 is preferable.4) Required languages in English and Bahasa Melayu.5) Ability to supervise and work independently.6) Able to meet deadline.7) Possess positive work attitude, result driven, self-motivated and a good team playerWorking hours:Mon- Fri, 8:30am-5pmSat: 8:30am-1pmWHATSAPP UNTUK BOOK SESI INTERVIEW:HUBUNGI MS MOON 014-308 2806RECRUIT ADVANCE SDN BHD (1466416-K)**Job Types**: Full-time, Permanent**Salary**: RM2,500.00 - RM3,000.00 per month**Benefits**:- Free parking- Opportunities for promotion- Professional developmentSchedule:- Day shift- Monday to FridaySupplemental pay types:- Attendance bonus- Overtime pay- Performance bonus- Yearly bonus**Education**:- Bachelor's (preferred)**Experience**:- with QA: 1 year (preferred)**Language**:- bahasa (preferred)- English (preferred)Ability to Commute:- Chemor (preferred)Ability to Relocate:- Chemor: Relocate before starting work (preferred)
