Regulatory Activities Jobs in Bergisch Gladbach

Coordinates with technical and regulatory leadership authority the regulatory activities of other RA professionals related to new and approved products on a domestic or international basis.May serve as Global RA program team representative for one or more programs through development More...

In your role as a Regulatory Affairs Manager you will be involved in the development of ATMPs.You will support the Regulatory Affairs department in preparing and reviewing approval documents for our products in cell and gene therapy.You will compile dossiers and take care of the submi More...

In your role as a Regulatory Affairs Manager you will be involved in the development of ATMPs.You will support the Regulatory Affairs department in preparing and reviewing approval documents for our products in cell and gene therapy.You will compile dossiers and take care of the submi More...

Your roleYou are working in the Clinical Research & Development department which conducts firstinman clinical trials and Phase III proofofconcept studies for our new assets worldwide.You ensure GCP compliance for the clinical trials in collaboration with Quality Assurance to suppo More...

In this role you will be responsible for collecting reviewing maintaining and archiving essential regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP) E6 ICH Guidelines and other regulatory guidance documents and Clinical Trials Regulati More...

Job Description Tasks – Requirements Capture and Management: Collaborate with stakeholders to capture define and manage systemlevel requirements. Translate highlevel customer requirements into detailed functional and nonfunctional specifications. Maintain tr More...

Job Description Tasks Coordination and oversight of all tasks related to type Investigation in concurrence with internal stakeholders and the competent authority Advising of all departments of the design organisation in all questions regarding airworthiness operational suit More...

As Senior Manager Process Development at Miltenyi Bioindustry you will lead a group driving the technical development of cells and vectors for our customers. The focus is on cell and gene therapy as well as lentiviral vector services implemented on our advanced inhouse platforms e.g. More...

In the Clinical Trial Execution Service department you will support our study processes and activities in line with our gotomarket strategy for investigational medicinal products (IMPs) particularly in haematological and oncological indications. You will be the expert and first point More...

We are seeking a highly motivated and resultsoriented Product Manager (mfd) to join our team and manage the assigned portfolio of CliniMACS Disposables / Bags. In this role you will play a pivotal role in driving product development market positioning and customer satisfaction within More...

You will be responsible for creating and maintaining user manuals in English for our innovative medical devices always ensuring compliance with current standards and regulatory requirements.  You will organize the translation of user manuals into the languages relevant to the tar More...

In Scalables growing Data Department we are looking for developers for our new team Data Integration & Management. This team has a twofold mission: On the one hand the team is responsible for bringing data products (e.g. machine learning models) into production. Furthermore provid More...

In Scalables growing Data Department we are looking for developers for our new team Data Integration & Management. This team has a twofold mission: On the one hand the team is responsible for bringing data products (e.g. machine learning models) into production. Furthermore provid More...

In our R&D department you join a highly motivated multidisciplinary team of biologists immunologists chemists and engineers who are eager to work with you to develop the next generation T cell therapies.In this exciting role you will join a highly ambitious team that develops next More...

Are you a talented and motivated lifescience modelling & simulation scientist with experience in the pharma industry Do you enjoy driving innovation and setting new boundaries in physiologicallybased (PBPK/DDI) modelling This position offers you this and more exciting work in an i More...

You are working in the Clinical Research & Development department which conducts firstinman clinical trials and Phase III proofofconcept studies for our new assets worldwide.As Clinical Trial Manager you are responsible for the planning execution  and management of all aspect More...

You will be the main point of contact for our proprietary operating system based on Embedded Linux both in our project and in daytoday operations. You will create a unified architecture and roll out the system across our new devices taking into account regulatory and security requirem More...

You will play a pivotal role as a (Senior) C Software Engineer (mfd) for clinical software developing advanced software solutions for our clinical instrument portfolio ensuring seamless hardware integration and upholding the highest standards of quality and compliance in the medi More...

In the Clinical Trial Execution Service department your role will support our trial processes and activities in line with our gotomarket strategy for Investigational Medicinal Products (IMPs) especially in hematological and oncological indications. As a key contact for bioanalytical s More...

You will play a pivotal role as a (Senior) C Software Engineer (mfd) for clinical software developing advanced software solutions for our clinical instrument portfolio ensuring seamless hardware integration and upholding the highest standards of quality and compliance in the medi More...