Regulatory Affairs Officer
1 week ago
Job Description
- Develop and execute regulatory affair and system for new or existing medical device products
- Lead the Regulatory Affair function with company’s project teams
- Monitor regulatory requirements; assure compliance with company quality system and international standards such as ISO, FDA and CE.
- Establish appropriate communication with external suppliers/vendor, regulatory authorities, certifier and hospitals.
- Perform regulatory gap analysis and propose solutions for new and existing products
- Provide sound regulatory documentation and decisions
- Conduct annual auditing process according to company’s QMS and ISO regulatory system
- Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
- Review medical protocols or SOPs with local and global hospitals and health authorities
Job Requirement
- Bachelor’s degree in biomedical/bioengineering/bioscience or related discipline
- 2-3 years working experiences in relevant field, fresh graduate is welcomed to apply
- Preferred to have basic knowledge in regulatory compliance and ISO Quality management System (QMS), knowledge in ISO 13485 is preferred.
- Ability to manage projects with tight schedule
- Strong oral and written communication and presentation skills, fluent in Chinese is added advantage.
- Good interpersonal skills
- Ability to independently identify compliance risks and escalate when necessary
- Prefer to have experience in medical device development.
**Salary**: RM4,000.00 - RM5,000.00 per month
**Benefits**:
- Free parking
- Health insurance
- Opportunities for promotion
- Professional development
Schedule:
- Flexible hours
- Monday to Friday
-
General Affair Officer
5 days ago
Senai, Malaysia JOBBUILDER Full timeFollow-up local and foreign workers daily meals. - Responsible for the cleaner, office and production of clean work. - Responsible for monitoring the activities of the company security guards. - Patrol inspection system(security). - Assist consulting production workers. - Monitor stationery inventory. - Follow-up local and foreign workers transportation. -...
-
Customs & Excise Officer
2 weeks ago
Senai, Malaysia KEVATECH SDN BHD Full time_**About the Role**_ We are looking for a dedicated and detail-oriented **Senior Customs & Excise Officer** to manage import/export operations and duty exemption processes. You will play a key role in ensuring smooth and compliant cross-border logistics, especially under the LMW (Licensed Manufacturing Warehouse) framework. - **What We Offer**_ -...
-
HR Officer
1 week ago
Senai, Malaysia KAIFA TECHNOLOGY MALAYSIA SDN BHD Full time**Responsibilities**: - Responsible in all Human Resources initiatives which include Recruitment Of Foreign Expatriate and Foreign Operators, Contract Wages Administration, Employee Relations (Foreign), updates of employee personal files, preparation of HR letters and reports. - To handle the foreign worker employment by establishing strategies and plans to...
-
HR Officer
19 hours ago
Senai, Johor, Malaysia HAITIAN MACHINERY (MALAYSIA) SDN. BHD. Full timeResponsibilitiesAssist in implementing daily human resources management, including work related to recruitment, employee training, performance management, C&B and employee relations all HR-related work.Responsible for implementing daily management of administrative affairsAssist in building a positive organizational atmosphere and labor discipline in the...
-
Human Resources Officer
3 days ago
Senai, Johore, Malaysia Haitian Group Full time 40,000 - 60,000 per yearResponsibilitiesAssist in implementing daily human resources management, including work related to recruitment, employee training, performance management, C&B and employee relations all HR-related work.Responsible for implementing daily management of administrative affairsAssist in building a positive organizational atmosphere and labor discipline in the...
-
Operation Supervisor
5 days ago
Senai, Malaysia Agensi Pekerjaan Inter Island Sdn Bhd Full time1. Manage and supervise factory personnel training, administrative affairs, and material handling processes. 2. Plan and oversee the operation and management of the administrative affairs at the Malaysia plant, improving work efficiency and effectiveness. 3. Prepare the annual budget for the plant and monitor its execution to ensure cost control and...
-
Senai, Malaysia Koda Woodcraft Sdn Bhd Full time**Job Description: -** - To administer and oversee accommodation of hostel affair and to ensure hostels are compliant with Worker’s Minimum Standard of Housing and Amenities Act 2019. - Responsible for matters related to company hostels such as rental, tenancy renewal and etc. - Responsible in monitoring and liaising with contractors or vendors on the...
-
Compliance Executive
1 week ago
Senai, Malaysia JOBBUILDER Full time**Responsibilities**: - To assist the Compliance Officer to manage corporate affairs of Compliance Department of the Manager. - To assist in preparing Directors’ Resolutions, Minutes, Statutory Forms, Annual Returns and other compliance documents. - To assist in developing, implementing, and managing compliance policies, procedures, and frameworks in...
-
Safety Officer
2 weeks ago
Senai, Malaysia MINDE Group Full timeWe are looking for: Safety Officer Industry:Electrical/ Infrastructure Location:Senai, Johor, Malaysia **Job Description**: - Ensure workplace safety through guidelines, inspections, and compliance. - Conduct risk assessments and implement risk-reduction measures. - Provide safety training and ensure regulatory adherence. - Investigate accidents and...
-
Account Officer
2 weeks ago
Senai, Malaysia LIMA BINTANG LOGISTICS SDN BHD Full time**Position: Account Officer** **Why Join Us?**: **1. Great Pay**:Earn 30% more income than the average market salary. - Enjoy a rewarding salary that goes beyond industry standards, recognizing your good work with significant financial rewards. **2. Fast-Track Career Growth: Clear career ladder allow multiple promotion even less than 1 year!** - Experience...