Job Description

1) To assist in registration/approval for the medical devices in different countries.
2) Maintain internal and source company databases of regulatory approvals
3) 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 submissions
5) Liaise with regulatory authorities and designated agents on all registration matters including to the Malaysian medical device regulatory requirements.
6) Compile and submit required documents and provide responses to questions via return applications to currently marketed products.
7) Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
8) 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 superior QUALIFICATION AND EXPERIENCE
1) 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 player Working hours:
Mon- Fri, 8:30am-5pm
Sat: 8:30am-1pm WHATSAPP UNTUK BOOK SESI INTERVIEW :
http://www.wasap.my/60143082806/QAindeed
HUBUNGI MS MOON 014-308 2806
RECRUIT 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 development

Schedule:

• Day shift
• Monday to Friday

Supplemental 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)