Regulatory Affairs Koordinator (m/f/d)

medi GmbH & Co. KG Bayreuth Presence / Mobile Professional experience Quality management, quality assurance Full time Approval of medical devices. Biocompatibility. Rules. Design the future of safe medical devices! As a coordinator (w/m/d) Regulatory Affairs and biocompatibility, you play a key role in the approval and regulatory evaluation of our products. You ensure that national and international requirements are met and actively contribute to safe medical devices. Become part of our team and introduce your expertise to ensure quality and safety at the highest level! About us Around 3,000 medians worldwide develop innovative solutions for more quality of life – including 1,800 at our headquarters in Bayreuth. Our aim: to enable users to obtain maximum therapeutic results in the medical field and a unique body feeling in the sports and fashion segment (CEP and ITEM m6). We work as a team to set new standards with products and concepts – scientifically sounded and on high-tech level. What connects us to medi? We work in the team to make people feel better around the world – with know-how, heart and the need to grow together. With us counts every idea, every helping hand and every contribution to the whole.

Advice: You take over the holistic care and advice on processes for the approval of medical devices and their biological safety in the context of the conformity assessment procedure. Regulations: You support the monitoring of national and international standards, laws and guidelines and coordinate their requirements in the fields of expertise. Documentation: You will review relevant documents from product management, research and development and quality assurance for technical documentation and ensure the final conformity assessment. Assessment: You create biological evaluations and support the issue of admission and registration documents as well as audits. Design: You contribute to the conceptual development and revision of specifications for technical documentation, admission and registration.

Completed studies in natural sciences, law, medical technology or engineering At least one year of professional experience in regulatory issues or quality management systems related to medical devices Knowledge of medical device law Quality and Project Management Very good knowledge of German and ideal English (GER-Level B2)

30 days vacation, flexible working time models and the possibility of mobile work form the basis of your work-life balance. Look forward to Christmas money (13th monthly salary) and holiday money – as an appreciation for your use. Your health is at our heart, so an ergonomic workplace with height-adjustable desk, physiotherapy in the house as well as sports and health services awaits you. We promote your professional and personal development with a wide range of training and individual training. For your family we offer childcare grants, reserved kita courses and support in caring for family members. With the flexible free time compensation – hourly or throughout the day – you can also create room for what is important to you. In our operating restaurants you can enjoy daily changing, discounted dishes – coffee, cocoa and water are free. Take advantage of corporate benefits, regional discounts with the medi Card and attractive employee conditions on our products of medi, CEP and ITEM m6. There are plenty of free parking spaces available in our car park – you will also receive a petrol voucher every month. .