Clinical Affairs Project Lead at Danaher Corporation in Singapore

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Microsystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Shape the Future with Us! At Leica Microsystems, we have 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. Joining Leica Microsystems means contributing to scientific discoveries and supporting surgeons in making critical decisions. Our advanced microscopes and AI-based image analysis solutions enable users to gain profound insights into development and engineering challenges. Here, you will work on meaningful projects alongside passionate colleagues, driving progress and pushing the boundaries of what’s possible. Learn about the Danaher Business System which makes everything possible. 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. 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; develop and maintain Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports; and 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 and ensuring compliance with applicable and emerging regulatory, statutory, ethical, and company requirement, and support internal and external audits, inspections, and notified body assessments related to clinical affairs activities. The essential requirements of the job include: 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). Travel, Motor Vehicle Record & Physical/Environment Requir