Senior Consultant UDI & Regulatory Affairs (m/f/d)

P36; Hessen; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading life sciences company in Germany is seeking a candidate to lead implementation projects for their UDI Platform at international life sciences firms. You will support customers in product launch, coordinate teams, and contribute to the platform's development based on feedback. The ideal candidate has 5-7 years of experience in the life sciences or medtech field and strong project management skills. This role includes hybrid work options and a supportive company culture focused on work-life balance.

Leistungen

Flexible work hours

Retirement plan contributions

Disability insurance

Ergonomic workspace

Drinks and snacks

Qualifikationen

• 5–7 years of experience in life sciences or medtech, ideally UDI or regulatory affairs.
• Experience in international implementation projects.
• Understanding of regulatory requirements like MDR, FDA UDI, GS1, EUDAMED.
• Experience with SAP Business Technology Platform or willingness to learn about cloud technologies.

Aufgaben

• Support customers in product launch projects and build relationships.
• Lead implementation projects for p36 UDI Platform in life sciences.
• Advise customers on efficient UDI management processes.
• Coordinate interdisciplinary teams of experts.
• Collaborate with sales and customer success teams.
• Document best practices and shape delivery methodology.
• Drive further development of UDI Platform based on customer feedback.

Kenntnisse

Project management (classical & agile)

Strong communication skills

Analytical thinking

Solution-oriented approach

Fluent in German

Fluent in English

Ausbildung

Several years of experience in life sciences or medtech

Experience with regulatory requirements (MDR, FDA UDI, GS1, EUDAMED)

Tools

SAP Business Technology Platform

AWS

Jobbeschreibung

This is what we have in store for you:

• We listen to your feedback, and you’ll have a direct influence on shaping your future and the future of p36.
• A secure, permanent position with a 38-hour workweek in an innovative and constantly growing environment.
• Hybrid work options with flexible hours and attractive compensation that rewards exceptional performance.
• A family‑friendly company with an excellent work‑life balance, a contribution to retirement plans, and disability insurance.
• An extraordinary team spirit that combines professionalism with fun. We live and breatheNew Work.
• An ergonomic workspace with hardware tailored to your needs, plus drinks, snacks, and plenty of parking spaces.
• And much more...

Your profile:

• 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.
• 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.

You want to know more about the daily work in this position and what it's like to work at p36?

Are you passionate? Then apply now!

Do you have any questions about the application process? Then please feel free to contact Michelle by telephone on [phone], byEmail, or viaLinkedIn.

Your job:

• You will actively support our customers in product launch projects and build long‑term, trusting relationships.
• You will lead implementation projects for our p36 UDI Platform at international life sciences companies.
• You will analyse customer situations and actively advise our customers on implementing efficient UDI management processes with our solution.
• You will coordinate interdisciplinary teams of technical specialists, UDI experts and market experts.
• You will work closely with our sales and customer success team.
• You will share your knowledge, document best practices and actively help shape our delivery methodology.
• You will contribute customer feedback and drive the further development of our UDI Platform together with the product team.