Head of Regulatory for a core product incl. Project Management

Vivalyx GmbH; Köln; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Vivalyx GmbH, a medical technology startup, seeks a Head of Regulatory Affairs to lead product registration and compliance. Join a passionate team dedicated to innovation in organ failure solutions, ensuring regulations meet while having a meaningful impact on healthcare.

Leistungen

Mobile working conditions

Professional development and career growth

Attractive employee participation program

Qualifikationen

• Several years of experience in regulatory positions in medical device sector.
• Expertise in ISO 13485, ISO 14971, 21 CFR 820, and MDR.
• Knowledge of IEC 60601 and IEC 62366 preferred.

Aufgaben

• Lead registration and market launch of a product.
• Craft and implement strategies to meet regulatory requirements.
• Write regulatory documents and manage negotiations with partners.

Kenntnisse

Regulatory Affairs

Project Management

Proficiency in Microsoft Office

Fluent in English

Ausbildung

Technical or scientific degree or equivalent training

Jobbeschreibung

At Vivalyx, a medical technology startup based in Aachen, 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.

Tasks

As the Head of Regulatory Affairs and Product Management, you will lead the registration and market launch of a dedicated product. You will be the go-to person for regulatory matters of one of our core products, both within our team and to external partners. Your responsibilities will include crafting and implementing strategies to meet regulatory requirements, from strategic planning to preparing technical documentation, in collaboration with our internal team and external partners. Given our small team size, you will also be hands-on in writing regulatory documents. Additionally, you will manage negotiations with partners and suppliers, ensuring that our operations comply with quality management standards such as ISO 13485 and 21 CFR 820.

Requirements

Requirements

• 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 and project management, including liaising with regulatory bodies
• Experience with ISO 13485, ISO 14971, 21 CFR 820, and MDR
• Preferably, knowledge of standards such as IEC 60601 and IEC 62366
• Proficiency in Microsoft Office and fluent in English, both written and spoken
• Residence within a maximum commute time of 1.5 hours to Cologne and availability to work from the office at least once a week for team collaboration

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.

We look forward to hearing from you by July 18.

Head Of Product • Cologne, North Rhine-Westphalia, Germany