Clinical Affairs Project Lead

Danaher Corporation; Singapore; Vor Ort; SGD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Remote work eligible

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Clinical evaluation

Regulatory affairs

Medical writing

Clinical research

Process improvement

English fluency

Ausbildung

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

Jobbeschreibung

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 (https://danaher.com/our-businesses) 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 (https://www.danaher.com/how-we-work/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 Requirements:

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

It would be a plus if you also possess previous experience in:

• Execution end-to-end of clinical trials
• Formal training in Good Clinical Practices.
• Experience in study design and statistics.

Leica Microsystems, a Danaher operating company, 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. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

At Leica Microsystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Microsystems can provide.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com .