Regulatory Affairs Manager (m/f/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.

At our location in Aachen we are hiring a

Regulatory Affairs Manager (m/f/d)

Job Profile/Responsibilities

  • Creation and maintenance of technical documentation for medical device approvals in the European and international markets
  • Research of international regulatory requirements and guidelines for relevant changes
  • Execution of European and international medical device approval and registration procedures
  • Processing of approval and registration amendments
  • Advise colleagues on regulatory implications for product development, testing, and manufacturing projects
  • Communication with internal and external parties
  • Active participation in cross-functional and international projects

Your Profile

  • Completed scientific, medical, engineering, or technical studies or other relevant education
  • At least 3 years of professional experience in medical device regulatory affairs (experience with Class III medical devices desirable)
  • Very good knowledge of European medical device regulations, guidelines, and standards (knowledge of US FDA medical device regulations desirable)
  • Experience in communication with Notified Bodies and/or the US FDA
  • Experience with quality management systems according to EN ISO 13485
  • 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

Please send your application to Angelika Will (e-mail: career@adhesys-medical.com).

Adhesys Medical GmbH
Pauwelsstraße 17
52074 Aachen | Germany

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

While applying for the job please refer to jobvector

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