Head of Department (m/f/d) Regulatory Affairs
Your tasks:
· You will take over the management of the Regulatory Affairs department and coordinate the approval of medical devices under MDR while adhering to the agreed deadlines
· You lead the employees of the Regulatory Affairs department both professionally and disciplinarily and are the first point of contact for your employees
· You are responsible for creating and maintaining the technical documentation for products
· My client is working together with the Johner Institute as part of the Fit for Future program to transfer the technical documentation of class 3 medical devices to a digital approval platform (eTD). In your role, you will actively support and shape this process.
· They are responsible for post-marketing surveillance and clinical data generation
· You are responsible for creating and updating clinical assessments
· You carry out the registration of products in DIMDI / EUDAMED and maintain our data
· You follow the regulatory and normative changes
· You compile the technical dossiers for international product approval as well as the documents for product registration by the parent company in non-European countries and maintain these documents
· You communicate with registration offices, authorities and my clients branches
· You create and maintain quality assurance regulations and internal documents
· You take part in internal and external audits and inspections
· You conduct training on the Castor eDC system for both German and international employees
Your profile:
· You have completed a technical or scientific degree, preferably biomedical engineering, microbiology, process engineering or similar.
· You have several years of professional experience in the approval of medical devices and the creation of technical documentation
· You have in-depth knowledge of the legal requirements for medical devices (e.g. Regulation (EU) 2017/745 MDR, EC and FDA guidelines)
· You are characterized by analytical, process and solution-oriented thinking and action, combined with very good technical understanding
· You are service-oriented, work in a structured and independent manner and have a high level of responsibility
· You are characterized by a team-oriented way of working combined with high communication skills
· You already have initial experience in managing employees