- Singapore Singapore
Kerja Kerja Dari Rumah Clinical Affairs Project Lead, Gaji tinggi SGD 10,000 di Leica Microsystems - Maukerja
Kongsi
Simpan
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
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 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
.
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
.
For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.
Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our commitment for brilliant solutions and insight.
Leica Microsystems is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
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 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
.
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
.
For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.
Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our commitment for brilliant solutions and insight.
Leica Microsystems is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
Peringatan Penting
Jangan pernah kongsikan maklumat bank atau kad kredit anda semasa memohon pekerjaan. Elakkan membuat sebarang pembayaran atau mengisi survey yang tidak berkaitan. Jika ada yang mencurigakan, sila laporkan iklan pekerjaan ini segera.
Lebih Lanjut