Head of Regulatory and PRRC for a core product incl. Project Management (m/f/d)

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 strategyProject management experienceConfident 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 spokenSelect benefitsCompany carPublic transport ticket (Deutschlandticket Job / JobTicket)Urban Sports Club membershipFlexible, mobile working arrangements and flat hierarchiesRegular opportunities for training and professional developmentEmployee stock option programWe look forward to hearing from you.Find more English Speaking Jobs in Germany on Arbeitnow