[Hiring] Clinical Affairs Project Lead @Danaher Corporation

Role Description

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
• Operations teams
• External clinical experts
• Study sites
• Regulatory authorities

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.

In this role, you will have the opportunity to:

• 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.
  • Developing and maintaining Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports.
  • Ensuring 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.
  • Ensuring compliance with applicable and emerging regulatory, statutory, ethical, and company requirements.
  • Supporting internal and external audits, inspections, and notified body assessments related to clinical affairs activities.

Qualifications

• 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).

Requirements

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

Benefits

• Comprehensive, competitive benefit programs that add value to our lives.
• Health care program.
• Paid time off.
• Flexible, remote working arrangements for eligible roles.