CODAN Medizinische Geräte GmbH specialises in the manufacture and distribution of medical transfer systems. With more than 60 years of research and development, CODAN is a respected supplier of high-quality medical devices. We have some 480 employees working on the development and manufacture of these successful medical devices at our headquarters in Lensahn.
The well-being and satisfaction of our employees is invaluable to us. So we are always keen to enable you to achieve the best possible work-family balance – because we as a company also benefit from satisfied employees!

Our Regulatory Affairs department has an immediate vacancy for a

Regulatory Affairs Manager (m/f/other)

Full- or part-time and permanent.

Your tasks:

You will be taking on responsible tasks in the field of Regulatory Affairs. You will be complementing and supporting our existing team of scientists and medical technicians with the following tasks:

• Creating, maintaining and updating the technical documentation of Class Is and IIa sterile medical devices
• Assessing the conformity of the documentation with the applicable regulations
• Independently implementing and maintaining the associated marketing authorisations/registrations
• Communication with customers, licensing authorities and notified bodies
• Leading on projects to implement new or amended regulations
• Internal contact person (m/f/other) for regulatory queries

Your qualifications:

The job offer is aimed at all applicants, who are interested in the advertised position and wish to take on interesting and new challenges. Ideally, you will have the following profile:

• Successfully completed technical qualification with corresponding further training/professional experience or degree, preferably in the fields of engineering (e.g. medical technology, biomedical technology) or life science (e.g. chemistry)
• Ideally professional experience in the field of Regulatory Affairs (medical technology), quality management or in a comparable position in a regulated environment
• In-depth knowledge of national and international standards and regulations relevant to marketing authorisation of medical devices, such as EN ISO 13485:2016 or Regulation (EU) 2017/745 (MDR)
• Affinity for creating marketing authorisation documentation
• Technical understanding
• Very good spoken and written German and English
• Very good knowledge of Microsoft Office
• Structured approach to tasks, flexibility, good communication and teamworking skills

We offer:

• Permanent contract of employment
• Owner-managed company
• Good accessibility via the A1 motorway and other roads
• Direct connection to the regional bus service
• Company car park with covered bicycle parking spaces
• Friendly and appreciative working atmosphere
• Home office possible in some areas by arrangement
• Overtime can be compensated either in the form of free time or in the form of payment
• Company canteen
• Benefits in kind
• Company medical care
• Company pension scheme
• Participation in company sports groups possible

If our job advertisement has aroused your interest, do not hesitate to get in touch. Please send your application by email. Contact person: Tim Lundbeck, Human Resources Manager

CODAN Medizinische Geräte GmbH
Stig Husted-Andersen Straße 11 · 23738 Lensahn · DE
Tel. +49 (0) 43 63 · 51 11 · Fax +49 (0) 43 63 · 51 12 14
E-Mail: personal@codan.de · www.codancompanies.com