Clinical Strategy & Operations Lead for Medical Devices (m/w/d)

Adhesys Medical GmbH is an international high-tech start-up and part of the Grünenthal Group. We develop and market innovative adhesives for medical applications. Our products can seal wounds on the skin as well as in the body within seconds. We are looking for the following person in the clinical department at our location in Aachen.

Clinical Strategy & Operations Lead for Medical Devices (m/w/d)

Job Profile/Responsibilities

  • Develop and implement global clinical development plan with focus on EU and US market and provide guidance on the clinical strategy pathway
  • Provide clinical contribution to User Requirement Specifications (URS), Target Product Profile (TPP) and risk assessment
  • Prepare all necessary documentation for submission of clinical trials during development (e.g. IB, protocols, etc)
  • Steer outsourced clinical activities
  • Continuously monitor efficacy and safety of the product and take appropriate measures
  • Support preparation of submissions to registration
  • Lead the Clinical subteam and steer clinical timelines and budget
  • Represent Clinical within Development Team and collaborate with and support all relevant functions
  • Establish and steer international Clinical Expert Meetings and Advisory Boards and build-up network with key opinion leaders, hospitals and physicians
  • Review and approve publications

Your Profile

  • Completed medical studies or other relevant education
  • At least 5 years of professional experience in clinical operations and development of medical devices
  • Experience with External & Internal Sealants/Hemostats desirable
  • Knowledge of European medical device regulations (MDR 2017/745), clinical relevant guidelines, and standards as well as US FDA medical device regulations desirable
  • Experience in communication with Notified Bodies and/or the US FDA
  • Very good knowledge of English and German (written and spoken)
  • Independent, structured, and responsible work ethic
  • Very good written and spoken communication skills

We offer

  • Young, dynamic and innovative environment in a high-tech company
  • Flexibility and start-up mentality
  • Flat hierarchies
  • Fun at work in a motivated team

Email your application to Angelika Will (Email: career@adhesys-medical.com).

Adhesys Medical GmbH
Pauwelsstraße 17
52074 Aachen | Germany

Email: career@adhesys-medical.com
Web: www.adhesys-medical.com

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About Adhesys Medical GmbH

Adhesys Medical GmbH ist ein internationales High-Tech-Startup und Teil der Grünenthal Gruppe. Wir entwickeln und vermarkten innovative Klebstoffe für die medizinische Anwendung. Unsere Produkte können sowohl auf der Haut, als auch im Körper Wunden innerhalb weniger Sekunden sicher verschließen.
More about Adhesys Medical GmbH

Salary 

Average salary for comparable positions is about € 61.528,00 gross per year. Depending on experience and qualifications, as well as other factors, this estimate may deviate to varying degrees from salaries actually to be expected.