Regulatory Affairs Manager (m/f/d)

Consulting our customers and the KEYMKR colleagues in regulatory issues Development and implementation of regulatory strategies for customer products Preparation, testing and updating of technical documentation according to MDR and IVDR Implementation of Gap analyses and evaluation of existing documentation Creation and support at 510(k) Submissions Accompanying the approval of medical devices in international markets Independent processing of customer projects Designing and developing our digital file MEDULUS® as well as KEYMKR internal processes

completed studies, for example in engineering, natural sciences, life sciences or comparable discipline at least 3 years of professional experience in Regulatory Affairs in medical technology well-founded knowledge of relevant regulatory requirements, in particular MDR / IVDR as well as relevant standards and MDCG guidance documents Experience in the creation and evaluation of technical documentation ideally knowledge of international licensing requirements, for example in the FDA / 510(k) Pleasure to quickly incorporate you into new products, companies and regulatory issues a pronounced customer and solution orientation as well as joy in direct exchange with different contact persons the ability to process and communicate complex regulatory issues in a comprehensible and practical manner a structured, careful and quality-conscious operation Joy in working independently and at the same time using the professional exchange in the team safe handling of digital tools and documentation systems as well as interest in digital modes very good knowledge of German and English in word and writing

We are Kununu Top Employers 2024 and 2025 diverse customer projects with exciting regulatory issues a lot of design space to introduce your own ideas and actively develop our processes and services an experienced, collegial and appreciation team that shares knowledge, supports each other and develops pragmatic solutions together direct customer contact and short decision paths regular internal and external training as well as further possibilities for individual development flexible and mobile work we work digitally with our customers a modern digital working environment in the Lübeck university district with ergonomic jobs Bicycle leasing as a salary increase and tax-free allowance the classics: 30 days holiday as well as an attractive and market-friendly remuneration Team events, workshops and afterworks Nutrition: Beverages, fresh organic fruit, salad and biscuits