(Senior) Clinical Affairs Manager (m/w/d)

Small things can do great things – with our miniaturized medical devices for stroke treatment, we help to maintain and improve the quality of life of thousands of people. Be part of our mission and thus part of something great. Our work ensures that many people can continue to have valuable ideas. Acandis needs you as: (Senior) Clinical Affairs Manager (m/w/d)

Project management of clinical trials before admission (Art. 62 para. 1 Regulation (EU) 2017/745) and after market launch (Art. 74 para. 1 Regulation (EU) 2017/745) national and international Establishment and preparation of study-relevant documents, presentations and templates in cooperation with the testing centres, including for use in the submission of authorities and ethics committees submission of all relevant documents to the Ethics Commission and/or competent authority Site management at the start-up activities of a study, close cooperation with the test centres before, during and after completion of the clinical trial (including Site Contract Management) Management of Safety Reporting (SAE/AE) and complaints in cooperation with Regulatory Affairs and Quality Management departments Safety Management and Safety Reporting (AEs/SAEs) to competent authority (e.g. BfArM); Communication with the authorities Care of study documents (Trial Master File)

Successfully completed study of natural sciences, for example in the fields of medical technology, biology, biochemistry, biotechnology, chemistry or a comparable field Ideally, first professional experience in the field of clinical studies, such as Clinical Research Associate (CRA) or Study Coordinator For the position as Senior Clinical Affairs Manager: At least five years of professional experience in the project management of clinical trials in the field of medical devices Knowledge of clinical trials and relevant regulatory requirements (e.g. GCP guidelines, ISO 14155, MEDDEV and MDCG guidelines, MPDG, MDR [EU] 2017/745) are of advantage Secure handling of common MS Office software (MS Word, Excel, Outlook) High level of team capacity as well as pronounced analytical and conceptual skills Very good knowledge of German and English in word and writing

We offer you a long-term professional perspective with a range of design and self-esteem! They work in an open atmosphere with short com­munication paths and close decision-making processes. An interesting, constantly growing product portfolio awaits you and the chance to grow further with our medium-sized company. Design your future in medical technology with ACANDIS! High job security Continuous growth Attractive remuneration Good operating climate Flexible working hours Close incorporation Occupational pensions Free business sports JOBV1_EN