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.

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.

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

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

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

Public transport ticket (Deutschlandticket Job / JobTicket)

Flexible, mobile working arrangements and flat hierarchies

Regular opportunities for training and professional development

We look forward to hearing from you.

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