Senior Manager Compliance and Certification coordinating external audits and compliance at D - Trust GmbH in Berlin. Ensuring regulatory adherence and leading audit preparation and execution.
About the role
- Senior Consultant for UDI & Regulatory Affairs at p36 GmbH, leading projects and customer relationships in the life sciences industry. Involved in implementing the UDI platform for international clients.
Responsibilities
- 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.
Job title
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