Global Clinical Affairs Project Lead (Remote Options)

Danaher Corporation; Singapore; On-site; SGD 120,000 - 180,000; Full time

Benefits offered by this job

Remote work eligible

Job summary

Leica Microsystems, a Danaher operating company, is seeking a Clinical Affairs Project Lead in Singapore. You will plan, execute and deliver clinical evidence for product portfolios, partnering with Regulatory, R&D, Quality and other teams to support market access and lifecycle management.

You will lead CEP/CER activities, coordinate PMCF plans, and ensure data is reflected in risk, claims and regulatory submissions. Fluency in English and 3+ years of clinical affairs experience are required.

Qualifications

• Advanced degree required in Medicine, Pharmacy, Biomedical Engineering, Life Sciences, or related field.
• Fluency in English (written and spoken).
• Minimum 3+ years of experience in Clinical Affairs, Clinical Evaluation, Medical Writing, Clinical Research, or related roles within Medical Devices or IVD.

Responsibilities

• Lead Clinical Evaluation Activities for new products and lifecycle management per EU MDR and global regulations.
• Support clinical studies and data collection to generate evidence.
• Drive process improvement and ensure compliance across regulatory, QA and clinical affairs activities.

Skills

Clinical evaluation

Regulatory affairs

Medical writing

Clinical research

Process improvement

English fluency

Education

Advanced degree in Medicine, Pharmacy, Biomedical Engineering, Life Sciences, or related field

Job description

Leica Microsystems, a Danaher operating company, is seeking a Clinical Affairs Project Lead in Singapore. You will plan, execute and deliver clinical evidence for product portfolios, partnering with Regulatory, R&D, Quality and other teams to support market access and lifecycle management.

You will lead CEP/CER activities, coordinate PMCF plans, and ensure data is reflected in risk, claims and regulatory submissions. Fluency in English and 3+ years of clinical affairs experience are required.