Regulatory Affairs Specialist

2 weeks ago


Kuala Lumpur, Malaysia Jack Scientific Sdn Bhd Full time

**About Us**:
SKY MEDIC GROUP HOLDING is a leading medical device company committed to providing high-quality healthcare solutions. We are seeking a dedicated Regulatory Affairs Specialist to join our team and ensure compliance with regulations and standards for our medical devices, both locally and internationally.

**Key Responsibilities**:
1) Liaising with Local Medical Device Authority such as Medical Device Authority (MDA) & Registered Conformity Assessment Body (CAB)

2) Liaising with international regulatory body such UKCA for registration & Certifications for Sky Medic -United Kingdom Branch

3) Conduct virtual meetings with manufacturers and notified bodies to discuss regulatory matters and ensure compliance.

4) Provide guidance to product development teams regarding specific product submission requirements.

**Qualifications**:
Bachelor’s degree in Regulatory Affairs, Life Sciences, or related field.

**Benefits**:

- International travel to United Kingdom ( Branch )
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and supportive work environment.
- Increment after Confirmation

**SKY MEDIC GROUP HOLDING is an equal opportunity employer.**

**Salary**: RM3,000.00 - RM3,500.00 per month

Schedule:

- Monday to Friday

Ability to Commute:

- Kuala Lumpur (required)

Ability to Relocate:

- Kuala Lumpur: Relocate before starting work (required)

Expected Start Date: 11/06/2023



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