Job details
| Location: | |
| Job Type: | Permanent |
| Discipline: | |
| Reference: | HLS/AF/QARM/090620C |
| Posted: | almost 4 years ago |
| Consultant: | Angel Fu |
| Consultant Email: | email Angel |
| Consultant Phone: |
Job description
Our client is a well-known MNC in Clinical Diagnostics industry.
Responsibilities
- Ensure on-time product registrations and handle all regulatory matters with Health Science Authority
- Assist and coordinate regulatory requirements of SEA dealer region
- Manage all product corrective actions and reporting to HSA with product specialists
- Enforce all Corporate requirements on compliance procedures
- Manage dealers’ requirements on compliance
- Represent Company’s SEA in industry associations and in front of regulatory bodies
- Hire, lead and coach direct reports in SEA QRA team to deliver the high quality work as well as ensure team members’ career development objectives as well as actions implementation
- Keep QRA leadership team and business leaders aware in new regulation update and prepare the team to address the regulatory improvement
- Keep QRA team’s high compliance level in all compliance requirements
- Demonstrate role model for team members in business integrity and collaborations
- Manage QRA functional budget and cost
Requirements
- Degree or higher in major medical, sciences or related fields
- Minimum 5 years of experience in regulatory environment of medical devices
- Excellent communication skills, strong knowledge of global regulatory and compliance requirements, able to meet
Please contact Angel Fu at +65 6950 0358 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion
EA License no: 16S8066 | Registration no: R1983939
Only successful candidates will be notified.