At Vivalyx, a medical technology startup based in Cologne, we're on a mission to save the lives of those suffering from organ failure.Our innovative approach aims to significantly improve the vitality and availability of donor organs. As we gear up for certification and related studies, we're seeking dedicated team members (m/f/d) to join us starting as soon as possible, for 32-40 hours per week.We provide the opportunity to work on groundbreaking technology that has a meaningful impact. You'll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program.Your roleAs the Head of Regulatory Affairs, PRRC and Product Management, you will lead the registration and market launch of one of our core products and act as the go-to person for all regulatory matters, both within our team and towards external partners. This role is based within commuting distance (max. 1.5 hours) of Cologne.Your responsibilitiesLead the registration and market launch of a core productAct as the primary point of contact for regulatory matters, internally and with external partnersCraft and implement regulatory strategies, from strategic planning to preparing technical documentationCollaborate closely with the internal team and external partners on regulatory deliverablesTake a hands-on role in writing regulatory documents given the small team size.Manage negotiations with partners and vendorsEnsure operations comply with quality management standards such as ISO 13485 and 21 CFR 820QualificationsPassion for working in medical technology developmentStrong sense of ownership, drive, independence, and commitmentA technical or scientific degree or equivalent trainingSeveral years of experience in a regulatory position in the medical device sector with broad responsibilities across the regulatory spectrum (i.e., companies with five or less people in regulatory such as startups or SMEs)Expertise in regulatory affairs, including liaising with regulatory bodies and developing regulatory strategyConfident acting as the primary point of contact for internal teams and external partnersExperience with ISO 13485, ISO 14971, 21 CFR 820, and MDRPreferably, knowledge of standards such as IEC 60601 and IEC 62366Strong technical/regulatory writing skills are importantHands-on, independent working style suited to a small-team / startup environmentNegotiation skills, with experience managing partner and vendor relationshipsProficiency in Microsoft Office and fluent in English, both written and spokenCompany carUrban Sports Club membershipFlexible, mobile working arrangements and flat hierarchiesRegular opportunities for training and professional developmentThis overview was written from the original listing to help you understand the role. Always confirm the specifics on the employer’s application page. #J-18808-Ljbffr
Standorte
arbeitnow Vivalyx GmbH Cologne · 10/21/2026 in Iserlohn, Köln Arbeitgeber: Primetime
SoSafe ist ein hervorragender Arbeitgeber, der dir die Möglichkeit bietet, in einem dynamischen und hochmotivierten Team zu arbeiten, das Vielfalt und Innovation schätzt. Mit flexiblen Arbeitszeiten, 33 Tagen Urlaub und einem individuellen Weiterbildungsbudget unterstützt SoSafe nicht nur deine berufliche Entwicklung, sondern sorgt auch für eine ausgewogene Work-Life-Balance. In Köln hast du die Chance, Teil eines schnell wachsenden Scale-ups zu werden, das sich aktiv für die Sicherheit in der digitalen Welt einsetzt und dir zahlreiche Möglichkeiten zur persönlichen und fachlichen Entfaltung bietet.
