Clinical Affairs Lead: Evidence & Regulatory Strategy

LEICA INSTRUMENTS (SINGAPORE) PTE LIMITED

Singapore

On-site

SGD 90,000 - 150,000

Full time

3 days ago

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Job summary

Leica Microsystems, a Danaher operating company, seeks a Clinical Affairs Project Lead in Singapore to plan and deliver clinical activities for assigned portfolios. You will work with Product Management, Regulatory Affairs, R&D, Marketing, Quality, Compliance, Legal, Commercial, Service, and Operations, and external clinical experts to generate evidence for global market access.

The role reports to the Director of Quality Assurance, Regulatory and Clinical Affairs and is based on site in

Qualifications

Advanced degree in a relevant field as required.
Minimum 3+ years of experience in Clinical Affairs, clinical evaluation, medical writing or related roles.
Experience in preparing clinical documentation per medical device regulations (EU MDR mandatory).
Fluency in English (written and spoken).

Responsibilities

Lead Clinical Evaluation Activities for new products and lifecycle management with CEPs and CERs per EU MDR and ISO 14971.
Support clinical studies or surveys plans, data collection and reports to generate evidence.
Drive process improvements and ensure compliance with regulatory and company requirements; support audits and inspections.
Collaborate with cross-functional teams (Regulatory, R&D, Marketing, QA, Legal, Operations) and external experts.