Clinical Affairs Project Lead

Leica Microsystems; Singapore; Presencial; SGD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health care program

Paid time off

Descripción de la vacante

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%

Formación

• 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).

Responsabilidades

• 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.

Conocimientos

Experience in Clinical Affairs

Medical Writing

Clinical Research

Regulatory understanding

Educación

Advanced degree in Medicine/Pharmacy/Biomedical/Life Sciences

Descripción del empleo

About the role

The Clinical Affairs Project Lead is responsible for the planning, execution, and delivery of all clinical affairs activities for assigned product portfolios and projects. This role partners closely with cross-functional stakeholders, including Product Management, Regulatory Affairs, R&D, Marketing, Quality, Compliance, Legal, Commercial, Service, and Operations teams, as well as external clinical experts, study sites, and regulatory authorities, to generate and maintain clinical evidence supporting global market access and product lifecycle management. This position reports to the Director of Quality Assurance, Regulatory and Clinical Affairs and is part of the Global RA/QA/CA Team located in Singapore and will be an on-site role.

Key responsibilities

• Lead Clinical Evaluation Activities for New Products and Lifecycle Management by authoring Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance with EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, MDCG guidance, ISO 14971, and applicable global regulations, including FDA and China requirements

• Develop and maintain Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports

• Ensure clinical evidence is appropriately reflected in risk management documentation, product claims, instructions for use, and regulatory submissions

• Support Clinical Studies and Scientific Evidence Generation through clinical studies or surveys plans, protocols, data collection, and reports in accordance with applicable regulations and internal procedures

• Drive Process Improvement and Maintain Compliance by contributing to the continuous improvement of clinical affairs processes, procedures, and tools

• Ensure compliance with applicable and emerging regulatory, statutory, ethical, and company requirements

• Support internal and external audits, inspections, and notified body assessments related to clinical affairs activities

About you

• Advanced degree in Medicine, Pharmacy, Biomedical Engineering, Life Sciences, or related field (Equivalent combination of education and experience will be considered)

• Minimum 3+ years of experience in Clinical Affairs, Clinical Evaluation, Medical Writing, Clinical Research, or related roles within Medical Devices or IVD

• Experience in preparing clinical documentation in accordance with medical device regulations (EU MDR mandatory, US and China are a plus)

• Experience in preparing and interpreting scientific and clinical data

• Fluency in English (written and spoken)

• Up to 10% travel (national mainly, international occasional)

About us

Leica Microsystems, a Danaher operating company, has been shaping the future for over 175 years with groundbreaking optical and digital solutions. With a culture rooted in customer focus, innovation, and teamwork, we lead the market in microscopy, imaging, and analysis, unveiling the invisible and empowering our customers to build a better, healthier world.

Benefits

Leica Microsystems offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.