Regulatory Senior Systems Specialist overseeing compliance for facilities operations at Banner Health. Managing inspections, documentation, and regulatory staff while ensuring workflow integrity and safety standards.
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
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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