Clinical Evaluation Manager
vor 1 Tag
Clinical Evaluation Manager (100%)
As one of the world´s leading manufacturers of cardio
- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.
The Medical Affairs Group is responsible for the design, conduction and evaluation of international first-in-man, regulatory submission and post-marketing trials.
**Your Responsibilities**
- Develop, revise and review clinical strategies/ clinical evaluation plans, clinical evaluation reports, PMCF plans and reports, summaries of safety and clinical performance and clinical investigator brochures. The documents are submitted to regulatory authorities and notified bodies
- Manage the quality, accuracy, and timely production of reports/ plans
- Support risk management activities like development and maintenance of product risk analyses and benefit-risk assessments
- Act as a core team member for product development projects
- Interfaces with risk management, R&D, regulatory affairs, study managers, biostatisticians and marketing
**Your Profile**
- MD or PhD ideally in the field of Cardiovascular Science
- 2-5 years of experience in medical writing preferably in a similar industry including clinical study reports and protocols, as well as a proven track record of publications in peer reviewed journals as the main author
- Excellent presentation and moderation skills, including technical editing and QC skills
- Good understanding of statistics, together with the ability to interpret complex clinical data
- Team oriented, accurate and self-dependent personality with an analytical working style
- Knowledge of MEDDEV 2.7/1 rev. 4 and MDR
- Experience with ISO 14971 and FMEAs, as well as knowledge in Risk Management is a plus
- Excellent command of spoken and written English, German is an advantage
Are you interested?
Location: Bülach | Working hours: Part-time | Type of contract: Unlimited
Job ID: 58844 | Martina Micciulla | Tel. +41 75 429 56 23
-
Clinical Evaluation Manager
Vor 7 Tagen
Zurich, Schweiz Proclinical VollzeitProclinical are recruiting a Clinical Evaluation Manager for a medical technology devices organisation on a permanent basis. As a Clinical Evaluation Manager, you will be handling the development of clinical strategies and submission documentation for first in ma, regulatory submission and post market trials for their class III...
-
Clinical Evaluation Expert
Vor 5 Tagen
Zurich, Schweiz Klenico Health VollzeitKlenico Health AG is a HealthTech company in Zurich and Berlin, which has set itself the goal of helping people with mental stress or illness. In cooperation with leading clinics in Europe, we have developed a web-based, CE-marked medical device software that guides healthcare professionals through the diagnostic process for mental disorders. We are...
-
Clinical Evaluation Manager
vor 1 Tag
Zurich, Schweiz BIOTRONIK SE & Co. KG VollzeitClinical Evaluation Manager (100%) As one of the world´s leading manufacturers of cardio - and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world...
-
Internship in Clinical Affairs
vor 2 Wochen
Zurich, Schweiz Lumendo AG VollzeitLumendo is a Medtech startup and a spin-off from ETH Zürich and EPFL Lausanne. We develop technologies to improve the efficiency and success rate of dental root canal treatments. Our goal is to improve the treatment by a disruptive cleaning technology and a novel, light-activated root canal filling material, thus helping people to keep their natural teeth...
-
Clinical Trial Manager
Vor 5 Tagen
Zurich, Schweiz Denali Therapeutics Vollzeit**Clinical Trial Manager** ***Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. **The Opportunity** The Clinical Trial Manager (CTM) is responsible managing the day-to-day operations of assigned clinical studies...
-
Clinical Regulatory Affairs Manager
vor 2 Wochen
Zurich, Schweiz Hays Vollzeit**My duties** - Directing and overseeing short-team and long-term planning of clinical data acquisition for regulatory submission initiatives - Leading pre-market clinical investigations and post-market clinical follow-up of the clients’ medical devices, with the goal to reach earliest possible approval of regulatory submissions - Designing clinical data...
-
Clinical Director
vor 2 Wochen
Zurich, Schweiz MSD VollzeitWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...
-
Clinical Trial Associate
vor 1 Woche
Zurich, Schweiz Proclinical VollzeitA leading Immunology company are recruiting for an experienced Clinical Trial Assistant to join their growing team on a 6 month contract with option to become a permanent employee after the initial assignment. This is a great opportunity to join a busy clinical team working across a variety of highly complex trials whilst taking on a wide range of...
-
Clinical Trial Associate
Vor 7 Tagen
Zurich, Schweiz Proclinical VollzeitA Mid-sized Pharma are recruiting for an experienced Clinical Trial Associate to join their growing on a 6 month contract with option to become a permanent employee after the initial assignment. This is a great opportunity to join a busy clinical team working across a variety of highly complex trials whilst taking on a wide range of responsibilities. The...
-
Eucan Regulatory Manager
Vor 7 Tagen
Zurich, Schweiz Takeda Pharmaceutical VollzeitAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **EUCAN Regulatory Manager - Clinical Trials** in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** Under supervision from a senior team member and/or in collaboration with EUCAN Regulatory Lead: -...