On-Site Clinical Affairs Project Lead

Leica Microsystems; Singapore; On-site; SGD 120,000 - 180,000; Full time

Benefits offered by this job

Health care program

Paid time off

Job summary

Leica Microsystems in Singapore seeks a Clinical Affairs Project Lead to drive planning, execution and delivery of all clinical activities for designated product portfolios. You will collaborate with Regulatory, R&D, QA, and cross-functional teams to generate robust clinical evidence for global market access and lifecycle management.

The role requires an advanced life sciences degree and 3+ years in Clinical Affairs or related fields within Medical Devices/IVD, with English fluency and up to 10%

Qualifications

• Advanced degree in a related life sciences field.
• At least 3 years in Clinical Affairs or related medical devices/IVD roles.
• Experience documenting clinical evidence in line with EU MDR and global regs (US/China a plus).
• Experience in preparing and interpreting clinical data.
• Fluent in English (written and spoken).
• Willingness to travel up to 10% (national and occasional international).

Responsibilities

• Lead Clinical Evaluation activities for new products and lifecycle management, author CEPs and CERs per EU MDR and MDCG guidance.
• Develop and maintain PMCF plans and PMCF evaluation reports.
• Ensure clinical evidence is reflected in risk management, product claims, instructions for use, and regulatory submissions.
• Support clinical studies and evidence generation with plans, protocols, data collection, and reports in accordance with regulations.
• Drive continuous improvement of clinical processes, procedures, and tools for compliance.
• Ensure compliance with regulatory, ethical, and company requirements.
• Support internal and external audits, inspections, and notified body assessments.

Skills

Experience in Clinical Affairs

Medical Writing

Clinical Research

Regulatory understanding

Education

Advanced degree in Medicine/Pharmacy/Biomedical/Life Sciences

Job description

Leica Microsystems in Singapore seeks a Clinical Affairs Project Lead to drive planning, execution and delivery of all clinical activities for designated product portfolios. You will collaborate with Regulatory, R&D, QA, and cross-functional teams to generate robust clinical evidence for global market access and lifecycle management.

The role requires an advanced life sciences degree and 3+ years in Clinical Affairs or related fields within Medical Devices/IVD, with English fluency and up to 10%