p36 GmbH

Senior Consultant, UDI & Regulatory Affairs

p36 GmbH

full-time

Posted on:

Location Type: Hybrid

Location: Bad Hersfeld • 🇩🇪 Germany

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Job Level

Senior

Tech Stack

AWSCloud

About the role

  • You actively support our clients during product launch projects and build long-term, trust-based relationships.
  • You lead implementation projects of our p36 UDI Platform at international life sciences companies.
  • You analyze client situations and proactively advise our clients to implement efficient UDI management processes with our solution.
  • You coordinate interdisciplinary teams of technical specialists, UDI experts, and market experts.
  • You work closely with our Sales and Customer Success teams.
  • You share your knowledge, document best practices, and actively help shape our delivery methodology.
  • You bring customer feedback and drive the further development of our UDI Platform together with the product team.

Requirements

  • You have several years of experience (at least 5–7 years) in the life sciences or MedTech environment, ideally with a focus on UDI or Regulatory Affairs.
  • You have experience working on international implementation projects.
  • You have a very good understanding of regulatory requirements (MDR, FDA UDI, GS1, EUDAMED).
  • Confident project management skills (traditional & agile) are part of your expertise.
  • You are characterized by strong communication skills, analytical thinking, and a solution-oriented approach.
  • You speak German and English very well — both in customer-facing contexts and within an international team.
  • Experience with SAP Business Technology Platform or AWS is a plus but not required — more important is your willingness to learn cloud technologies.
Benefits
  • A secure, permanent position with a 38-hour workweek in an innovative and steadily growing environment.
  • Hybrid working with flexible hours and attractive compensation that rewards outstanding performance.
  • A family-friendly company with an excellent work–life balance, including a contribution to company pension schemes and disability insurance.
  • An exceptional team spirit that combines professionalism and fun.
  • An ergonomic workspace with hardware configured to your preferences, as well as beverages, snacks, and ample parking.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
UDI managementproject managementregulatory requirementsanalytical thinkingsolution-oriented approach
Soft skills
communication skillsrelationship buildingteam coordinationcustomer feedback integration