Clinical Evaluation and Affairs Team Lead

vor 7 Monaten

Heerbrugg, Schweiz Leica Microsystems Vollzeit

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.

Leica Microsystems is one of the market leaders in the fields of microscopy, imaging, and analysis. We reveal the invisible and empower our customers to create a better and healthier world. Together with our customers, we transform scientific discovery. We empower surgeons to take well-informed decisions in life-changing procedures. We enable users to gain insights which help answer key questions concerning development and engineering. All of this is achieved with the combination of cutting-edge microscopes and AI-based image analysis.

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.

We currently offer a Clinical Evaluation and Affairs Team Lead position in our office in Heerbrugg, Switzerland. This is a hybrid role.

Clinical Evaluation and Affairs Team Lead (d/f/m)

Come join a fantastic team As a Clinical Evaluation and Affairs Team Lead, you will have cross-functional responsibilities, which require cooperating with various departments such as Product Managers, Regulatory Affairs, R&D, Marketing, Compliance, Legal, Regional Commercial/Sales, Service, Operations/Manufacturing as well as other external partners or authorities.

YOUR RESPONSIBILITIES:

- Establishes Clinical Strategy, Clinical development plans, and Performs Clinical Evaluations of medical devices Class IIa and Class I, according to MDR 745/2017, MEDDEV 2.7/1 Rev. 4 and relevant MDCG Guidances (CEP/CER), and 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.
- Conducts Scientific Literature Searches to establish State of the Art and to identify relevant clinical data.
- Creates and maintains PMCF Plan and PMCF Report.
- Oversees and manages plans and execution of clinical operations activities
- Maintains and implements the Clinical Affairs Processes
- Collaborates with cross-functional teams to ensure integration of Clinical Evaluation outcomes into product development and product life-cycle
- Provides Clinical expert input into Study protocols
- Up to 20% travel

YOUR PROFILE
- Degree in Medicine / Medical Engineering/ Pharmacy or other human/clinical/medical science.
- 5+ years’ experience as a Clinical Evaluator, Clinical Research Associate, Clinical Project Manager, or other related professional role.
- Fundamental knowledge and good understanding of Clinical requirements from EU MDR, FDA, GCPs, clinical trial design, study development and project management.
- Experience in interpreting, preparing, writing, and presenting Clinical and scientific data and information.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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