Regulatory Affairs Project Manager for Medical Technology
(m/w/d)
What to do:
- Development and implementation of an approval strategy with the client
- Creation and maintenance of comprehensive project structure and process plans (progress, performance, deadlines, resources, costs)
- Classification of medical devices taking into account the intended purpose and marketing area
- Advising / monitoring suppliers / customers on the implementation of regulatory and normative requirements for medical devices
- Ensuring cooperation, delivery dates and performance in close coordination with the internal and external stakeholders of the overall project and continuous alignment with the requirements
- Supporting the approval/registration process
- Responsibility for the creation and maintenance of technical documentation
- Responsibility for the implementation of risk management, usability and clinical data
- Training customers, personnel or suppliers with regard to requirements
- Market and competition monitoring with regard to PMS (post market surveillance) worldwide
- Contact person for authorities and customers for product-related information
- Participation in selected (inter-)national congresses, seminars, exhibitions and conferences to coordinate with opinion leaders and customers
What you bring with you:
- A scientific / technical degree, e.g. degree in medicine, natural sciences, pharmacy, biotechnology or mechanical engineering, electrical engineering or medical technology
- Alternatively: Several years of experience in (inter-)national approvals of class I-IIb medical devices in Europe, USA and other countries
- Experience in assisting with FDA approvals: 510k and de novo procedures
- Profound expertise in the area of relevant medical technology guidelines and standards (2017/745 (MDR), 60601, 13485, 62304, etc.)
- Experience with medical software class A-C is desirable
- Experience in clinical data and usability is desirable
- A self-responsible and independent way of working
- Flexibility, initiative, persuasion and team orientation
- Very good written and spoken German and English skills, at least level C1
What you can expect:
- Work-life balance: flexible working hours and the option to work remotely
- Flat hierarchies with an informal culture
- Versatile further training oppurtinities
- A committed team that thrives on exchange and cooperation
- Regular team events /company parties
Do you see yourself with us?
Then send your application to our personnel manager Ms. Dipl.- Kff. Claudia Coenen
What we need from you:
- Complete application documents
- Earliest possible start date
- Your salary expectations
Apply here by post
BYTEC Medizintechnik GmbH
Frau Dipl.-Kff. Claudia Coenen
Hermann-Hollerith-Str. 11
52249 Eschweiler
