Regulatory Affairs Specialist (m/w/d) (e.g. scientific graduate)
Immucor Inc., a global in vitro diagnostics (IVD) company with headquarters in Atlanta, USA, is a company specialized in immunohematology and corresponding automation systems. We distribute a full line of traditional immunohematology reagents and fully automated instruments and data management software to drive efficiency and productivity. Immucor strives to improve the quality of pre-transfusion testing by driving the implementation of automation especially for university hospitals and transfusion centers, blood donation services for hospitals and laboratory physicians. Our history of laboratory automation began in 1998 and since then we have continuously invested in generation systems.
To support our RA/QA team as part of the IVDR project, we are now looking for a temporary person for the Dreieich location
Regulatory Affairs Specialist (m/w/d)
(e.g. scientific graduate)
Range of tasks:
- Contribute to the quality oversight of IVD products according to ISO 13485, ISO 9001, IVDD, IVDR, cGMP standards and applicable national laws and guidelines
- Support the transfer of products currently CE marked under 98/79/EC to the IVDR (EU) 2017/746
- Support the registration of CE-marked Immucor Medizinische Diagnostik GmbH products within EEA under (EU) 2017/746 IVDR
- Support the definition of the regulatory strategy and manages regulatory submission activities for new product development activities and product maintenance for existing approved Immucor Medizinische Diagnostik GmbH IVD medical devices
- General support for RA/QA team and special projects, as needed
- Interpretation for new and changing regulatory requirements related to the (EU) 2017/746 IVDR, communicates impact to stakeholders, and develops implementation plans including gap and risk analysis
- Ensuring adequate documentation of European and global regulations and standards
- Ensure maintenance of regulatory documentation, e.g. Technical File
- Master's degree in biology, biotechnology or another related scientific discipline or comparable and already some work experience in a regulatory affairs role supporting registration of CE-marked IVD medical devices
- Ability to apply knowledge of ISO 13485, ISO 9001, ISO 14971, IVDD, IVDR and cGMP standards to the job
- You have very good knowledge of German and English
- You act with a strong service orientation, show excellent analytical and organizational skills
- Extensive PC knowledge, especially in Microsoft Office (Word, Excel, PowerPoint)
- Your outstanding teamwork and communication skills combined with commitment and conscientious working methods are prerequisites for this demanding task.
- Our corporate values of respect, integrity, teamwork and performance match your values.
- Working in an innovative, and forward-thinking company
- Challenging and versatile tasks in a motivated, international team
- Flexible working hours with home office option
- Sympathetic and cooperative working environment with a demanding and challenging work
- Security of an established, successful company
- Central location with good infrastructure in the Rhine-Main-area
- Regular Feedback about your personal and career development
Are you interested?
Then please send us your full application in German and/or English, stating your earliest possible starting date and salary expectations by email to
Mrs. Hannah Wortmann, Sr. Manager Regulatory Compliance and / or
Mrs. Franziska Hruby, HR Generalist
Immucor Medizinische Diagnostik GmbH | Robert-Bosch-Str. 32 | D-63303 Dreieich