Submission Specialist (m/f/d)

In order to act successfully on the national and international market in the future, we want to strengthen ourselves as the world market leader in the field of organic solutions. For this purpose, we are looking for a dedicated Submission Specialist (m/w/d) for the following tasks: Preparation, review and submission of technical documentation and dossiers for medical devices (class I to III) at national and international designated bodies and authorities Coordination with cross-functional teams (e.g. marketing, R&D, QS, QK) to ensure complete and conformal documents and follow-up of submissions Monitoring regulatory changes, updating of authorisation documents and processing of amendments or extensions Maintenance of tracking systems and document management Coordination and quality control of translations of regulatory documents in German and/or English Reporting to Head of Medical Devices

You have: A successfully completed medical or scientific study (pharmaceutical, bioscience, or related fields) or a completed study of medical technology - Regulatory Affairs (M.Sc.), Regulatory Affairs – Medical Devices (M.Sc.), or a comparable qualification. Certification/specialization in Regulatory Affairs is an advantage Multiannual professional experience in Regulatory Affairs or Submissions in Medical Devices (at least 3 years) Knowledge and knowledge in the field of regulatory requirements (e.g. MDR, ISO 13485), knowledge of e.g. EUDAMED, FDA or NMPA desirable Insufficient know-how on “life cycle management” (processing of submissions after their approval, such as product variations, extensions, location registrations, etc.) Professional experience in the GMP environment would be desirable Safe handling of the MS Office package Very good English skills in word and writing Sufficient German knowledge (at least level B2) A structured, precise and reliable operation High communication and tuning capability with internal and external stakeholders High sense of responsibility and quality The ability to work both independently and in the team in a flexible and flexible manner

Flat hierarchies & fast decision paths Friendly colleagues Small teams Good work-life balance Attractive remuneration Occupational pension and supplementary health insurance Space for ideas, initiative and design Hybrid work (partly possible) Good further education and training opportunities Modern jobs JobRad program Corporate Benefits Free choice of hot and cold drinks Fresh button system (Welovefresh GmbH) with daily meals and snacks Parking directly on site