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Head of Regulatory Affairs

Job Description

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

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