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

<h2>At Vivalyx, a medical technology startup based in Cologne, we're on a mission to save the lives of those suffering from organ failure.</h2><p>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<strong> team members (m/f/d) to join us starting as soon as possible, for 32-40 hours per week.</strong></p><p>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.</p><h3>Your role</h3><p>As 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.</p><h3>Your responsibilities</h3><ul><li><p>Lead the registration and market launch of a core product</p></li><li><p>Act as the primary point of contact for regulatory matters, internally and with external partners</p></li><li><p>Craft and implement regulatory strategies, from strategic planning to preparing technical documentation</p></li><li><p>Collaborate closely with the internal team and external partners on regulatory deliverables</p></li><li><p>Take a hands-on role in writing regulatory documents given the small team size.</p></li><li><p>Manage negotiations with partners and vendors</p></li><li><p>Ensure operations comply with quality management standards such as ISO 13485 and 21 CFR 820</p></li></ul><h3>Qualifications</h3><ul><li><p>Passion for working in medical technology development</p></li><li><p>Strong sense of ownership, drive, independence, and commitment</p></li><li><p>A technical or scientific degree or equivalent training</p></li><li><p>Several 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)</p></li><li><p>Expertise in regulatory affairs, including liaising with regulatory bodies and developing regulatory strategy</p></li><li><p>Project management experience</p></li><li><p>Confident acting as the primary point of contact for internal teams and external partners</p></li><li><p>Experience with ISO 13485, ISO 14971, 21 CFR 820, and MDR</p></li><li><p>Preferably, knowledge of standards such as IEC 60601 and IEC 62366</p></li><li><p>Strong technical/regulatory writing skills are important</p></li><li><p>Hands-on, independent working style suited to a small-team / startup environment</p></li><li><p>Negotiation skills, with experience managing partner and vendor relationships</p></li><li><p>Proficiency in Microsoft Office and fluent in English, both written and spoken</p></li></ul><h3>Select benefits</h3><ul><li><p>Company car</p></li><li><p>Public transport ticket (Deutschlandticket Job / JobTicket)</p></li><li><p>Urban Sports Club membership</p></li><li><p>Flexible, mobile working arrangements and flat hierarchies</p></li><li><p>Regular opportunities for training and professional development</p></li><li><p>Employee stock option program</p></li></ul><p><strong>We look forward to hearing from you.</strong></p><p>Find <a href="https://www.arbeitnow.com">Jobs in Germany</a> on Arbeitnow</a>