Germany Job Openings

Extedo GmbH

Requirements Engineer / Business Analyst (m/f/d) Regulatory Information Management

FULL TIME

September 6, 2024

Make the world better with us!
EXTEDO helps health authorities and pharmaceutical companies around the world develop and bring new drugs and vaccines to market faster and more safely.
As an internationally leading provider of software and services in regulatory information management (RIM), we support life sciences organizations in implementing the requirements of the regulatory authorities for their products. Our solutions thus ensure that medicines and vaccinations reach where they are needed faster and, at the same time, more safely: with the patients. Regulatory authorities around the world also rely on us to review submissions and ensure they meet the highest standards of drug safety.
For our location in Ottobrunn near Munich (or in remote within Germany) we are actively seeking a
Requirements Engineer / Business Analyst (m/f/d) Regulatory Information Management
As a Requirements Engineer / Business Analyst (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/x EVMPD, 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.
At EXTEDO you will find

Flexible working hours. Structure your day yourself! You enjoy working from home but also like coming into the office
Benefits such as an employer-funded pension scheme, 30 days of vacation, free parking, company events
Mutual respect and appreciation - regardless of gender, nationality, disability, age and identity
The feeling of being part of the team from day one, with a great onboarding program
A very friendly and relaxed working atmosphere, without a dress code, with flat hierarchies and lots of freedom

We are looking forward to receiving your application via our website: https://career.extedo.com/Requirements-Engineer-Business-Analyst-mfd-Regulatory-Info-eng-j327.html
Job Type: Permanent
Work Location: Remote

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