We at Modis Life Sciences staff projects throughout Germany for renowned clients in the pharmaceutical, biotech and chemical industries. From start-ups, family businesses and medium-sized companies to global big players, we have a wide range of customers and requirements.
Then we are looking for you for a temporary cooperation of initially 24 months, on a project of our customer, a renowned company in the pharmaceutical / biotech industry, in the southern greater Ulm area.
What you can do for us
- Assessment and reporting of complex work packages/development work related to strictly regulated medical device development in English language within the development matrix (e.g. design control plans & reports, preparation of design reviews and project milestones documentation, as well as support for risk management or human factor engineering files), according to regulatory requirements.
- Advise, support and relieve team leadership in project work for regulated medical devices and combination products from early development phases through to launch.
- Provision of technical expertise in device teams in the application and maintenance of processes, methods and tools to efficiently design and optimise project work in a matrix organisation, e.g. design control standards, design review / milestone reports, CFR820-related reports, project planning, standard framework for project documentation incl. templates, documentation / archiving, etc.
- Assumption of complex special responsibilities within the scope of development, e.g. for the preparation, review and creation of development files
- Assumption of special tasks within the design control process, e.g. independent creation and maintenance of project plans in coordination with the project management, coordination of changes with the help of EDP systems or transfer tasks, etc.
The skills that are needed
- Master's/Bachelor's degree in engineering or natural sciences with several years of professional experience in technical project management or experience in the design control process (21 CFR 820.30).
- Technological as well as regulatory expertise in the development of medical and combination products and profound knowledge in GMP are desirable
- *Very good language skills in German and English.
- Current CV in tabular form with job description.
- Employment references
- University degree/training certificate
- Certificates of further education
- If applicable, work permit, visa, Blue Card...
Why you are in the right place when working with us
- Team spirit and diversity
- Work-life balance
- Attractive remuneration
- Employee benefits
- Numerous opportunities for training
- Team and sports events
- Global network
- Attractive employee referral program
Benefits may vary based on position and location. You can find an overview of our benefits under Careers and Benefits on our website.
We are looking forward to getting to know you.
Send us your application directly. We'll be happy to answer any questions you may have. We welcome applications from people who contribute to the diversity of our company.
AKKA & Modis, now Akkodis, is a global powerhouse of technologies and digital solutions in smart industry and one of the leading providers. With over 50,000 engineers and digital experts in 30 countries, we support our customers and partners worldwide in the areas of Life Sciences, IT and digital engineering. We are looking for talented people who can work with us in driving innovation and digital transformation for a smarter and sustainable future. We put our employees first and believe that together we can make a big difference. That's why Kununu ranked us third among Germany's best employers in the consulting sector in 2021.
Phone +49 761 38908 213