Specialist Regulatory Affairs Operations and Labelling (f/m/d)

at  Hartmann

At HARTMANN, we’re all in to help, care, protect and grow. We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make.
Join our team as

QUALIFICATION:

• University degree in science or technical sciences or an equivalent qualification
• Ideally initial professional experience in the medical device environment or another regulatory field of work
• Knowledge and/or experience in the areas of medical devices, technical documentation and regulatory product documentation, conformity assessment and post-market surveillance
• Ideally a strong interest in and knowledge of electronic regulatory document control and management systems and associated processes
• Open and competent attitude when working with internal partners
• IT affinity and proficiency with the MS Office package
• Strong communication skills as well as persuasiveness and assertiveness
• Fluent written and spoken German and English

• In this cross-functional and global role, you will ensure the labelling and implementation of products on time according to regulatory requirements
• Global monitoring and improvement of regulatory product documentation and conformity assessments
• You will be responsible for the master files of the package inserts, labels and artwork and check them for correctness and the necessary labeling requirements in the review and approval process
• Develop proposals to improve the IT infrastructure for the management of regulatory product documentation
• Provide strategic and technical consulting on regulatory issues
• Final evaluation of product-related regulatory requirement