Head of Regulatory for a Core Product incl. Project Management

Vivalyx

Innovative Preservation Solutions for Organ Donations

Innovative Preservation Solutions for Organ Donations

Cologne

Munich

• Mid-Level

• Hybrid

• Finance/Legal & Compliance

2025-07-04T00:01:28+00:00

2025-07-04T00:01:28+00:00

About Company
About Company
About Company

TL;DR

TL;DR
✨ The Role in One Sentence

Vivalyx GmbH is seeking a Head of Regulatory Affairs and Product Management to lead the registration and market launch of a core product.

📋 What You'll Likely Do
  • 40%: Lead registration and market launch of a dedicated product.

  • 30%: Craft and implement strategies to meet regulatory requirements.

  • 30%: Manage negotiations with partners and suppliers, ensuring compliance with quality management standards.

🧑‍💻 Profiles Doing This Job
  • High Priority: Experience in a regulatory position in the medical device sector.

  • High Priority: Expertise in regulatory affairs and project management.

  • High Priority: Knowledge of ISO 13485, ISO 14971, 21 CFR 820, and MDR.

📈 How This Role Will Look on Your CV
  • Led regulatory affairs and product management for a medical technology startup.

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Vivalyx

101-200

FTE

Innovative Preservation Solutions for Organ Donations

Vivalyx specializes in advanced preservation systems aimed at enhancing organ donation processes. By leveraging cutting-edge biotechnology and manufacturing techniques, they ensure optimal conditions for organ storage, ultimately improving transplant success rates.

Funding

€6.31M

HQ City

Aachen

Revenue Model

B2B

Employee Count

101-200

Last Funding Round

04/2024

Stage

Early

Team Growth

33%

YoY Website Traffic Growth

-70%

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/ Hybrid

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SIMILAR by:

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Organ Donation Tech

Vivalyx

Head of Regulatory for a Core Product incl. Project Management

Full-Time

Microsoft Excel

English (R)

Cologne

/ Hybrid