Business Systems Analyst
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Job Description
Structured overview of role & requirementsAbout This Role
Implement system and process improvements for Document Control using PLM system (Agile) including change orders and compliance.
Represent Document Control in project teams, participate in requirements definition, testing, and ensure regulatory and quality compliance.
Maintain and update documentation procedures, provide Agile system support, and manage complex Document Control tickets and approvals.
Minimum Requirements
6-10 years of equivalent work experience or a university degree.
Experience in Regulatory/Quality within a medical device company.
Strong knowledge of PLM systems (Agile preferred) and Change Control principles for Document Control.
Training in Quality System Regulations, ISO, Project Management, and Quality Systems Validation.
Ideal Candidate Profile
Experienced in cross-functional project collaboration for system/process improvements in regulated environments.
Proficient in both functional and technical aspects of PLM (Agile) with demonstrated ability to manage documentation and compliance in a medical device context.
Skilled communicator able to liaise between business stakeholders, technical teams, and regulatory groups ensuring clear requirements and defect resolution.