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Regulatory Affairs Specialist (w/m/d)

INSIDE

Innovation in therapy and diagnosis - that is what we are committed to. Leading medical technology companies worldwide rely on our 3D tracking technology – we have been the global market leader in this field for over 20 years. Our expertise as an innovative high-tech company for the realization of modern, digital solutions in medical application fields is a central component of our success. People work for NDI at four locations worldwide. The cultural diversity in our globally active company and the demands of the high-tech medical industry make for a stimulating work environment. The knowledge, enthusiasm and experience of our employees are essential to our success. And everyone knows everyone by name – including our colleagues in Canada, the USA and Hong Kong. We trust each other, are honest with each other and can celebrate with each other. And we do it across hierarchies – that’s what makes work fun!

TASKS

Do you keep track of complex regulatory requirements and work in a structured and independent manner? Then we look forward to receiving your application! Your tasks:

Ensuring compliance with regulatory requirements in the area of material compliance (e.g. RoHS, REACH, PFAS) and processing corresponding customer inquiries
Maintenance and use of relevant databases for material declarations
Monitoring and implementation of normative requirements (MDR, FDA, ISO 13485)
Support in quality management, especially in document management, training and CAPA processes
Review and approval of technical documents as well as support for projects and production inspections

PROFILE

Successfully completed technical or scientific studies or comparable training
Several years of experience in the field of regulatory affairs in medical technology, especially in the area of material compliance
Very good knowledge of the relevant standards and regulations (ISO 13485, MDR, FDA) and knowledge of quality management are an advantage
Very good written and spoken German and English skills
Independent, structured and assertive personality with team spirit and strong communication skills

How can I apply?

We prefer the application by e-mail via our e-mail address
careers@ndieurope.com.
However, you are also welcome to send your application by mail to the following address:

NDI Europe GmbH
Human Resources
Güttinger Straße 37
78315 Radolfzell

What documents are needed and in what formats?

We welcome a brief cover letter with information about the position you are applying for. We would also like to receive your CV, references and proof of relevant further training. Please let us know your notice period or your desired starting date and your salary expectations. Please send us your documents in PDF format. Optimal: A file that is not larger than 4 MB.

How do I make sure you received my application?

You will receive your personal confirmation of receipt from us within 1 – 3 working days. Between Christmas and New Year we have a shutdown. Here we will contact you again directly afterwards.

Can I also submit a speculative application?

You are welcome to apply with the description of your desired position if you do not find the right position for you in our job offers.

What is the application process like?

You can find the course of our application process here.

Who is the contact person for my application?

Your contact person is Ms. Annette Schönepauck, our HR Generalist.

What happens to my data after my application?

Your personal data will be used by us exclusively for the application process and will not be passed on to third parties without your personal consent. After the end of the application process, we will automatically delete your data. You have the option of requesting the complete deletion of your data at any time by sending us a short e-mail to careers@ndieurope.com. If you have any further questions about data protection, please feel free to contact us at dsgvo@ndieurope.com.

Can I apply through my mobile device?

Our site is designed for mobile devices, so you can send us your application from a mobile device.

Where can I find the currently advertised positions?

You can find all our vacancies here.

Do you also offer internships and theses?

You are always welcome to apply for an internship or to conduct a thesis in our company.

Do you also offer apprenticeships?

We would be pleased if you would like to complete your training in our company. You can find an overview of the currently open apprenticeship positions here.