Regulatory Affairs

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.

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) for Sanctuary Health Sdn Bhd 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

**Salary**: RM2,500.00 - RM3,000.00 per month

**Benefits**:

- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development

Schedule:

- Day shift

Supplemental pay types:

- Attendance bonus
- Commission pay
- Overtime pay
- Performance bonus

Ability to commute/relocate:

- Ipoh: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- QA/QC: 1 year (preferred)