Subject Matter Expert IDMP Requirements Engineer mfd Regulatory Information Management 277312

EXTEDO; Ottobrunn; Hybrid; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

EXTEDO is seeking a Subject Matter Expert IDMP / Requirements Engineer to bridge business objectives and technical solutions in Regulatory Information Management. This role involves collaborating with cross-functional teams to define and document requirements, ensuring software solutions meet client needs, while fostering a diverse and inclusive work environment.

Leistungen

Flexible working arrangements

Comprehensive onboarding and training

30 days of vacation

Occupational pension scheme

Qualifikationen

• Sound knowledge of regulatory and quality processes in the life sciences industry.
• Experience in software development; agile methodologies is a plus.
• Fluent in English; German is a plus.

Aufgaben

• Collaborating with the Product Owner to gather and document business requirements.
• Developing detailed business and functional requirements.
• Supporting the agile product development team throughout the development lifecycle.

Kenntnisse

Analytical thinking

Team player

Problem-solving skills

Knowledge of regulatory processes

Knowledge of IDMP / SPOR data

Jobbeschreibung

Imagine a world where lifesaving 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, cure, and 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 locations in Ottobrunn near Munich or remotely within Germany, we are actively seeking a Subject Matter Expert IDMP / Requirements Engineer (m/f/d) in Regulatory Information Management.

Your role: As a Subject Matter Expert IDMP / Requirements Engineer, 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 to ensure our software solutions meet client needs. You will also support the entire agile product development team, working closely with cross-functional departments and business stakeholders.

Your tasks include:

1. Collaborating with the Product Owner to gather, analyze, and document business requirements.
2. Developing detailed business and functional requirements, including user stories and acceptance criteria.
3. Working closely with the agile product development team to ensure a clear understanding of requirements and supporting them throughout the development lifecycle.
4. Conducting regular meetings with stakeholders to refine requirements and manage expectations.
5. Performing data analysis to support decision-making and problem-solving.
6. Facilitating communication between business stakeholders and the development team.
7. Assisting in developing and maintaining project documentation, including project plans, roadmaps, and status reports.
8. Participating in quality assurance activities to ensure that the final product meets the requirements.
9. Supporting user acceptance testing (UAT) and coordinating feedback sessions with stakeholders.

Your profile:

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

Why join EXTEDO?

• Modern Working Conditions: Enjoy 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 comprehensive onboarding and training, you'll feel part of the team from day one. We invest in your future through continuous learning and development opportunities, empowering you to grow your career while making a difference in healthcare.
• Passionate About People: Collaborate with a diverse team of experts from over 20 nationalities, united by a passion for innovation and healthcare excellence. We foster diversity and inclusivity, creating an environment where your ideas are valued 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

Key Skills: Databases, System Design, Cybersecurity, System Architecture, Requirements Gathering, Curriculum Development, DoD Experience, FISMA, etc.

Employment Type: Full Time

Experience: Years

Vacancy: 1

Requirement Engineer • Ottobrunn, Bavaria, Germany