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

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 role

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.

Your responsibilities

• Lead the registration and market launch of a core product

• Act as the primary point of contact for regulatory matters, internally and with external partners

• Craft and implement regulatory strategies, from strategic planning to preparing technical documentation

• Collaborate closely with the internal team and external partners on regulatory deliverables

• Take a hands-on role in writing regulatory documents given the small team size.

• Manage negotiations with partners and vendors

• Ensure operations comply with quality management standards such as ISO 13485 and 21 CFR 820

Qualifications

• Passion for working in medical technology development

• Strong sense of ownership, drive, independence, and commitment

• A technical or scientific degree or equivalent training

• 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)

• Expertise in regulatory affairs, including liaising with regulatory bodies and developing regulatory strategy

• Project management experience

• Confident acting as the primary point of contact for internal teams and external partners

• Experience with ISO 13485, ISO 14971, 21 CFR 820, and MDR

• Preferably, knowledge of standards such as IEC 60601 and IEC 62366

• Strong technical/regulatory writing skills are important

• Hands-on, independent working style suited to a small-team / startup environment

• Negotiation skills, with experience managing partner and vendor relationships

• Proficiency in Microsoft Office and fluent in English, both written and spoken

Select benefits

• Company car

• Public transport ticket (Deutschlandticket Job / JobTicket)

• Urban Sports Club membership

• Flexible, mobile working arrangements and flat hierarchies

• Regular opportunities for training and professional development

• Employee stock option program

We look forward to hearing from you.

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