Head of Product Omnisol incl. Regulatory

vor 4 Wochen

Aachen, Deutschland Vivalyx GmbH Vollzeit

We, Vivalyx, are a medical technology startup from Aachen dedicated to saving people suffering from organ failure. Our goal is to significantly increase the vitality and number of donor organs. The company is currently in the preparation phase for certification and the associated studies. For this purpose, we are looking for new colleagues (m/f/d) starting from 01.06.2024 (or later) for 32-40 hours a week.

Tasks

As the Head of Product incl. Regulatory, your role encompasses driving the development, registration, and market entry of our core product, while also acting as the primary contact for regulatory issues among both our team and external partners. You will be tasked with formulating and executing strategies to adhere to regulatory requirements, overseeing everything from strategic planning to the preparation of technical documentation in collaboration with our internal and external teams. Since we are a small team, you will be also required to write regulatory documents yourself for the initial period. Additionally, you will negotiate agreements with partners and suppliers, ensuring our operations align with quality management standards set forth by ISO 13485 and 21 CFR 820.

Requirements

• Motivation and enjoyment of work – especially in medical technology and development

• Strong ownership, drive, independence and commitment

• Proven leadership capabilities

• Technical or scientific degree or comparable training

• Several years of professional experience in the medical device sector, preferably in product management, RA and project management including contact with regulatory bodies

• Preferably experienced in applying ISO 13485, ISO 14971, 21 CFR 820, and MDR

• Confident handling of Microsoft Office and proficient English in spoken and written form

Benefits

We offer the opportunity to work on highly innovative cutting-edge technology with a good purpose in a dynamic, highly qualified, and highly motivated team. In addition, we work very flexibly, mobile, and in flat hierarchies. We also offer further training and career advancement opportunities, as well as an attractive employee participation program.

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