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

Imagine a world where life-saving medicines and vaccines reach those who need them most, faster and more safely. At EXTEDO, this is not just a vision – it’s our daily mission.

We are driven by the profound responsibility to ensure that every treatment, every cure, and every vaccine reaches patients without unnecessary delays. Our work empowers health authorities and pharmaceutical companies around the globe to navigate the complex regulatory landscape with confidence, knowing they have a trusted partner in the life science industry for managing and streamlining regulated information at every step of the pharmaceutical product lifecycle. With over 25 years of innovation, 100+ employees, and 20+ nationalities, EXTEDO stands as a leader in Regulatory Information Management (RIM). 

For our location in Ottobrunn near Munich or in remote within Germany we are actively seeking an Subject Matter Expert IDMP / Requirements Engineer (m/f/d) Regulatory Information Management.

As a Subject Matter Expert IDMP/ Requirements Engineer (m/f/d), you will play a crucial role in bridging the gap between our business objectives and technical solutions. Your primary responsibility will be to support the Product Owner in defining requirements, ensuring that our software solutions meet the needs of our clients. You will also support the entire agile product development team, work closely with cross-functional departments and business stakeholders.

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

Why EXTEDO?

• Modern Working Conditions: Welcome to a relaxed and friendly work environment with an open-door policy. We understand the importance of work-life balance, offering flexible working arrangements.
• Personal & Professional Growth: With a comprehensive onboarding and training program, you will feel like part of the team from day one. We invest in your future with continuous learning and development opportunities, empowering you to grow your career while making a real difference and enjoying a collaborative environment.
• Passionate About People: You’ll collaborate with a diverse team of experts from more than 20 nationalities who are united by a shared passion for innovation and excellence in healthcare. Join us in fostering diversity and equality for all! Be part of a team that values inclusivity and celebrates individuality. Together, let’s create an environment where your ideas are heard and everyone can thrive.
• Wellbeing included! Enjoy regular company and team events, a canteen allowance, 30 days of vacation and a comprehensive occupational pension scheme.

Company: EXTEDO GmbH 

Country: Germany 

State/Region: Bayern 

City: Ottobrunn 

Postal Code: 85521 

Job ID: 277312

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