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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 are united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where your unique viewpoint matters. 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! Leica Microsystems has shaped 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.
This Clinical Evaluation Manager position is a remote role, with regular on-site presence in our office in Heerbrugg for cross-functional collaboration, team and culture building, and visits to study centers (as needed).
Responsibilities and cross-functional collaboration: you will work with Product Managers, Regulatory Affairs, R&D, Marketing, Quality, Compliance, Legal, Regional Commercial/Sales, Service, Operations/Manufacturing as well as external partners or authorities.
Your Responsibilities
* Establishes Clinical Strategy, Clinical development plans, clinical evaluation routes, and performs Clinical Evaluation Reports of medical devices Class IIa and Class I, according to MDR 745/2017, MEDDEV 2.7/1 Rev. 4 and relevant MDCG Guidances for CEP/CER and PMCFP/PMCFR, and class 2 US FDA if applicable.
* Evaluates data from pre-clinical testing, clinical studies, literature, post-market surveillance, risk management, complaints and post-market clinical follow-up.
* Oversees and manages all clinical evaluations of LMS Medical portfolio (~10), while maintaining and implementing the Clinical Affairs Processes
* Coordinates planning and execution of clinical operations activities as inputs/outputs to clinical evaluations, and provides Clinical expertise into Study protocols and study design.
* Collaborates with cross-functional teams to ensure integration of Clinical Evaluation outcomes into product development and product life-cycle.
Your Profile
* Degree in Medicine, Medical Engineering, Pharmacy or other human/clinical/medical science.
* 5+ years’ experience as a Clinical Evaluator, Medical Writer, Clinical Project Manager, Clinical Affairs Manager, or other related professional role.
* Fundamental knowledge and good understanding of Clinical evaluation requirements from EU MDR, FDA, as well as GCPs, clinical trial design, study development and project management. Knowledge on the clinical evaluation requirements for China is a strong plus.
* Experience in interpreting, preparing, writing, and presenting clinical and scientific data and information.
* Up to 30% travel (including presence in the office, as needed).
Get more insight. Learn more about what we do and who we are by watching our company video “We Are Leica.” For more information, visit www.danaher.com.
Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Other
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