Employee (m/w/d) Regulatory Affairs

Оccupation: Regulatory Affairs Manager

Connecting people and technologies. Design the Perfect Match for our customers. Always the right expert: find yourself for the respective challenge - this is our claim at FERCHAU and we are looking for you: as an employee for one of our customers. We implement exciting projects for well-known customers in the fields of pharmaceuticals and life science and convince daily with sound expertise and professional know-how. Do you want to fully develop your potential? We offer you an environment with diverse tasks, new challenges and permanent opportunities, where you can grow further and sharpen your profile.

Senior Consultant (m/w/d)

Your tasks:

Your task area

• Support in the production of technical documentation for medical technology products
• Support for the regular up-to-dateness review of Technical Files in particular Ensuring the Essential Requirements for CE Declaration of Conformity MDD and fulfilling the General Safety and Performance Requirements for CE Declaration of Conformity MDR
• Compilation of device test reports for technical documentation
• Analysis and evaluation of international regulatory requirements
• Implementation of measures to ensure international transportability of medical technology products
• Creation, revision and maintenance of process instructions and monitoring of changes to SOPs

This is what awaits you

• Unlimited employment contract
• Occupational pension
• Special holiday for important private occasions e.g. wedding, move, birth
• Holiday allowance by collective agreement
• Continuing training at our in-house institute, the FERCHAU Academy (e-learnings, trainings and seminars)
• Premium programme for recommendations from new Members:

Your qualifications:

Your profile

• Complete university studies, preferably in medical technology or comparable
• First experience in technical documentation and regulatory requirements of medical devices
• Experience in the field of RD, QM or approval of complex systems of advantage
• Good knowledge of German and English

Looking for the next challenge? Then we should get to know each other! The fastest way to apply directly - is to apply online under the VA66-40028-F code with Mrs Tamara Mohr. Let's take the next level together and bring technology forward!

Joblocations:

63743 Aschaffenburg, BAYERN, GERMANY