Jobbeschreibung
NSF is a growing, global, public health and safety organization. Our mission, which we are passionate about is to improve human and planet health. NSF is dedicated to being a global leader in the testing, inspection, and certification industry. Our core business divisions include food, water, health sciences, sustainability, and international strategic registrations. Our services include standards development, testing, auditing, certification, training and advising our clients. Headquartered in Ann Arbor, Michigan, with over 2,500 employees worldwide we provide services in over 170 countries at more than 50 offices and laboratory locations.
The consultant will support our national and international clients in the analysis of clinical and non-clinical data and develop necessary documentation.
- Consulting our clients on the implementation of clinical affairs projects
- Clinical evaluations in accordance with Regulation (EU) 2017/745 on medical devices
- Systematic literature search in relevant databases (EMBASE, PubMed, etc.)
- Identification and analysis of scientific literature and data
- Evaluation of clinical experience data (post-market surveillance)
- Communication with clients, authorities, notified bodies, and manufacturers
- Completed university degree in sciences, preferably with post doc/Phd
- Knowledge and some experience in the field of medical devices is an advantage
- Experience or knowledge of those topics is prefered:
- Clinical evaluations according to MEDDEV 2.7/1 and Regulation (EU) 2017/745 on medical devices (MDR)
- Performance evaluations according to Regulation (EU) 2017/746 on in vitro diagnostics (IVDR
- Biological assessments according to ISO 10993, ISO 18562, ISO 14971, and MDR
- Plans and reports for post-market surveillance and post-market clinical follow-up according to MDR and IVDR
- Clinical investigations and PMCF studies according to MDR, MPDG and ISO 14155
- Enjoy reading lots of scientific literature
- Biostatistics
- High motivation to independently and responsibly work on new tasks
- Teamwork, flexibility, and strong customer orientation
- Enjoy working in a dynamic team
- Fluent German and English
- Confident use of common MS Office programs
- Technical understanding in the field of medical devices
- Able to handle complex project
- Organizational skills and solution-oriented thinking
The opportunity to learn and grow in an international company within a dynamic team.
- Training Program
- Pension scheme
- Bonus
- Culture Buddy
- Remote work available after 6 months
Our culture is rooted in four central values: Doing the Right Thing, Treating People Well, Relentlessly Pursuing Excellence, and Embracing Unity Within NSF. These principles drive all our actions.
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