Jobs

StingOrg GmbH is mandated by its customers because of its expertise in quality, project and process management.

As experts, we analyze processes and find sustainable solutions together.

To do this, we use our specialist knowledge and passion, roll up our sleeves and lend a hand right from the start.

To further expand our growth, we are looking for: 

Senior Consultant Medical Device Regulation (m/f/d)

As a Senior Consultant (m/f/d) MDR, you will work independently on innovative projects in which you will accompany our customers as a reliable contact person in the implementation of the MDR.

Your tasks are

• Transfer and development of the technical documentation to the requirements of the EU MDR
• Support in complying with gap assessment results of existing documentation on new requirements
• Processing of gaps for clinical evaluations, post-market surveillance and other changes
• Introduce modified processes to meet requirements

The profile we are looking for:

• A degree in engineering, ideally with a focus on medical technology
• Knowledge and experience of international standards: MDR, IVDR, GMP, ISO 13485, 14971 and QSR 820
• Experience in product and risk management
• Experience in planning, facilitating and documenting workshops
• Enforcement and implementation competences
• Mobility and readiness to be deployed in international locations
• Proficiency in written and spoken English

What we offer you:

• An innovative, open-minded and team-oriented corporate culture
• Challenging projects in an international environment with varying challenges
• Imparting methodological knowledge by means of sustainable and individual training programs for continuous further education

We look forward to receiving your documents and are looking forward to hearing from you how you would like to contribute your skills and interests to our team.

Please send your documents to:

StingOrg GmbH
Haferwende 3A
28357 Bremen
bewerbung@stingorg.de
Tel: 0421 43480770