Langer Medical GmbH, based in Waldkirch, Germany, which has been part of Brainlab in Munich since 2022, has specialized in the development and marketing of highly innovative medical technology for intraoperative neuromonitoring and neurostimulation for more than 25 years. Our products are groundbreaking in design and handling and form the basis for our worldwide growth. Langer Medical as well as the company itself have been honored several times in the past with various prizes and awards.Job DescriptionYou are interested in Regulatory Affairs or in the development of medical devices? As QM Consultant in our Regulatory Affairs team you will interact with Dr. Langer Medical departments and partners internationally and Regulatory Agencies from all over the world. Langer Medical products and be responsible for establishing the regulatory strategy. You will interpret regulatory requirements and implement them in projects.Collaboration on the creation, updating and review of the technical documentation before/after CE marking a new/changed medical deviceEvaluate and follow up design changes during the development and implementationParticipation in the documentation of product changes - change managementDiscuss regulatory topics with R&D colleagues and other departmentsEstablish global regulatory strategies for the medical devices of Dr. Langer Medical in collaboration with local partners of the Brainlab subsidiariesCompile regulatory submissions to be send to authorities e.g. Langer Medical employees in regulatory requirementsQualificationsDegree in (medical) engineering or life sciences preferred, but other degrees may be consideredKnowledge and experience of medical device regulations such as EN ISO 13485 and MDR (2017/745) as well as FDA 21 CFR part 820 (QSR) and MDSAPProfessional experience in regulatory affairs or regulatory compliance in the medical device field. Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D)Excellent English and proficient German written and verbal communication skillsAbility to communicate with all stakeholdersIndependent, structured and pragmatic working stylePersuasive powerAdditional InformationA mutually-supportive, international teamMeaningful work with a lasting impact on medical technology30 vacation days, plus December 24th and December 31stFlexible working hoursRegular team, and company eventsInternal company fitness programComprehensive training and continuing education opportunities offered by Brainlab SETOP 100 innovator and employer of the future 2022Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.