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Healthcare & Life Sciences

Quality and Regulatory Manager (Clinical Diagnostics MNC)

Job details

Location: Singapore
Job Type: Permanent
Discipline:
Reference: HLS/AF/QARM/090620C
Posted: 2 months ago
Consultant: Angel Fu
Consultant Email: email Angel
Consultant Phone: +65 6950 0358

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.