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Regulatory Affairs Application Support Consultant
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ABOUT ARCONDIS
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,
information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
About us
MISSION
Tasks and responsibilities
We are looking for an experienced Regulatory Affairs professional to join our dynamic international consulting team and play a key role on a project for one of our key clients.
- Facilitate business-IT interface - understand internal IT products and coordinate needs with business units.
- Ensuring technical support between the handling of operative master data, operative business units and regulatory units.
- Lead effort in analysing, managing, and alignment on solution releases e.g. process and data requirements, as well as the design, tests scripts authoring and execution.
- Support data management activities, e.g. master data management, data quality, security and integrity, preparation and implementation of data-related changes.
- Primary lead of internal & external partners or vendors to troubleshoot technical issues and coordinate system updates.
- Performing and reviewing business operations, like impact assessments, root cause analysis and process improvement.
- Liaising with sponsors, business SMEs, related units proactively engaging on regulatory changes and being implemented in the eDMS, RIMS and eSM systems.
- Create and maintain user requirement specifications and quality control documents as required by SOPs and processes.
STUDIES
**Profile**:
- Bachelor’s or higher degree in a scientific discipline (e.g. computer science, information systems, engineering, software development or natural sciences).
- Extensive knowledge of Regulatory Affairs business domain and business processes & data management.
- Ability to understand complex functional requirements/requests from business users and translate them into pragmatic and workable (technology) solutions.
- Strong agile process management mindset and ability to provide customer-facing support to identify value drivers and continuous improvement of processes and solutions.
- Knowledge and ability to install, document, and test software and hardware upgrades through required GxP Change Controls.
- Intrinsic motivation to making healthcare better around the globe.
