Subject Matter Expert IDMP / Requirements Engineer (m/f/d) Regulatory Information Management

Your Tasks - as important as our Software:

• Collaborate with the Product Owner to gather, analyze, and document business requirements
• Develop detailed business and functional requirements, including user stories and acceptance criteria
• Work closely with agile product development team to ensure a clear understanding of requirements and support them throughout the development lifecycle
• Conduct regular meetings with stakeholders to refine requirements and manage expectations
• Perform data analysis to support decision-making and problem-solving
• Facilitate communication between business stakeholders and development team
• Assist in developing and maintaining project documentation, including project plans, roadmaps and status reports
• Participate in quality assurance activities to ensure that the final product meets the requirements
• Support user acceptance testing (UAT) and coordinate feedback sessions with stakeholders

Your Profile - as good as our Solutions:

• Sound knowledge of regulatory and quality processes in the life sciences industry
• Knowledge of Article 57/xEVMPD, IDMP/SPOR data incl. Master and Meta Data Management
• Analytical thinking and basic technical understanding
• Experience in the field of software development, experience in agile methodologies is a plus
• Team player with good social and problem-solving skills
• Fluent in English, German is a plus

You are used to working independently and you have already worked in the life science area, especially Regulatory Affairs, Quality or IT environment. You are initiative, goal orientated and assertive and have joy in business development.

What we offer you: If you have any questions, please do not hesitate to contact us at +49 (0)89 189-454-321. We are looking forward to your application!