p36 GmbH · 1 month ago
Senior Consultant UDI & Regulatory Affairs (m/w/d)
United States
Full-time
Remote
Senior Level
5+ years expp36 GmbH is an innovative technology company that specializes in cloud-based software solutions for the life sciences industry. The Senior Consultant will actively support customers in product launch projects, lead implementation projects for the p36 UDI Platform, and coordinate interdisciplinary teams to ensure efficient UDI management processes.
Cloud Data ServicesInformation TechnologySaaSSoftware
Responsibilities
Du begleitest unsere Kund:innen aktiv im Rahmen von Produkteinführungsprojekten und baust langfristige, vertrauensvolle Beziehungen auf
Du leitest Implementierungs-Projekte unserer p36 UDI Platform bei internationalen Life-Sciences-Unternehmen
Du analysierst Kundensituationen und berätst unsere Kunden aktiv um effiziente UDI-Managementprozesse mit unserer Lösung zu implementieren
Du koordinierst interdisziplinäre Teams aus technischen Spezialist:innen, UDI-Expert:innen, und Marktexpert:innen
Du arbeitest eng mit unserem Sales- und Customer-Success-Team zusammen
Du teilst dein Wissen, dokumentierst Best Practices und gestaltest aktiv unsere Delivery-Methodik mit
Du bringst Kundenfeedback ein und treibst die Weiterentwicklung unserer UDI Platform gemeinsam mit dem Produktteam voran
Qualification
Required
You have several years of experience (at least 5–7 years) in the life sciences or medtech field, ideally with a focus on UDI or regulatory affairs
You have already worked on international implementation projects
You have a very good understanding of regulatory requirements (MDR, FDA UDI, GS1, EUDAMED)
Confident project management (classical & agile) is part of your expertise
You are characterised by strong communication skills, analytical thinking and a solution-oriented approach
You speak German and English very well – both in a customer context and in an international team
Preferred
Experience with SAP Business Technology Platform or AWS is a plus, but not a must – more important is your willingness to familiarise yourself with cloud technologies
Benefits
Zuschuss zur betrieblichen Altersvorsorge
Berufsunfähigkeitsversicherung
Company
p36 GmbH
p36 is a pioneering technology company specialized in driving cloud innovation for Life Sciences.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Robin Wennemuth
Co-Founder & CEO
Patrick Pfau
Geschäftsführer
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