Kerja Sepenuh Masa RCAQ Senior-Exec, Gaji tinggi MYR 5,000 di Iftitah Solutions (M) Selangor - Maukerja

JOB-DUTY

(Major responsibilities and target accomplishments expected of the position including the typical problems encountered in carrying out the responsibilities)

*MUST BE WELL-VERSE IN MDA APPLICATION

1. Handling all documentation for any submission which are related

2. Managing the RCAQ department as manager and less-supervise (coordinate meeting with department, well handling the division operation and task given the management)

3. Keeping records and licenses for company and individuals up-to-date & vendor registration and all related

4. Typing up legal documents such as an agreement or contract when needed

5. Performing legal research, such as product research, for registration

6. Coordinate with manufacturers and other firms to obtain and exchange information and documentation related to legal matters, such as completing the form for Medical Product Registration (MDA).

7. Conducted assessments of medical devices, including registration, re-registration, and change notifications, to ensure regulatory compliance.

8. Assess the urgency of situations and determine appropriate actions; monitor the status of pending items; provide follow-up; and keep management informed by communicating a wide variety of information.

9. Key in and update the legal application web-based Online Application System for Establishment Licensing, Medical Devices Registration, and In-Vitro Diagnostic (IVD)

10. Assisting and full handling in registration for ISO 13485 and other related

11. Key in and update the legal application of the AELB system for licensees.

12. Maintain legal management systems such as the Medical Devices Authority (MDA) & AELB.

13. Maintain and keep records and update all company’s vendors application for renewal and new submission

14. Aware of new information that is provided by the legal unit

15. Aware, registering, and preparing the training schedule for RPO courses & examinations

16. Keep records and update them for GDPMD requirements, filling system, and stock replacement for auditing purposes.

17. Management system, filing protocols, production of letters, and legal documents such as contracts related

18. Assisting in the renewal of licenses if any related.

Job Requirements

-Education: Degree & above in science background.

- more than 5 years of experience (especially in MDA registration)

- must English literate

Others Benefits:

* Medical claim (max RM 150/per month), you may claim for spouse and kids as well

* Outstation Allowance: Meal (RM 50 perday for local trip) & RM150 (perday/oversea trip)

* Hotel/accommodation : RM 250 pernight (claimable)

* Milage : claimable

* Laundry claim (if travel more than 2 days) : max RM 100

* HQ nearby Serdang Raya Selatan MRT (5 min walking distance)

* Replacement Leave Entitlement if working/outstation during off-day

* Annual Leave : 12 days yearly (prorate)

* Increase of leave after 2 yrs & above services

* Medical Leave : 14 days yearly (prorate)

* Paternity leave (7 days) / Maternity leave (98 days)

* Hospitalisation leave : 82 days

* Compassionate leave

* Extra leave during Hari Raya & Raya Haji

* Replacement Leave (if outstation/work during weekend)

* Dental benefit (serve more than 2 years)

* Yearly company re-treat

* Yearly company Iftar (Buka puasa) & Jamuan Raya

* Sport activities with colleagues

* Every Friday Company Activities (Yaseen with all staff) & Kuliah Agama with Ustaz (Online kuliah)

* Bumiputra base company (positive culture)

* Positive Career growth (Promotion)

* Yearly increment : based on KPI Merit and company discretion

Pay: RM4,000.00 - RM5,000.00 per month

Benefits:

• Additional leave
• Maternity leave
• Opportunities for promotion
• Parental leave

Work Location: In person