Business Analyst в Align Technology

In this role, you will…

Prepare required documentation related to the ClinCheck software for 510k submission procedure:

update and combine existing documentation,
create missed documentation,
cover ClinCheck architecture,
create design specifications,
update RTM
work on Risks Assessment for ClinCheck,
communicate with subject matter experts, software developers, regulatory team to close on the documentation part (ClinCheck SRS, Architecture, Design specification, Risks Assessment, RTM).

Communicate with ClinCheck BA team to get all required information on SRSs, RTMs;
Keep up-to date Master SRS, Master RTM, Master ClinCheck architecture;
Communicate with software developers and SQA engineers to clarify requirements;
Ensure tracing requirements from the documentation to the software product.

Work with Regulatory team on the Design Control process improvements related to the ClinCheck, including the process of DHF file creating and updating.
Maintain Software Specifications for ClinCheck app for the new features/projects:

Work closely to the Marketing/Clinical teams to clarify business requirements;
Work closely to Dev, SQA, BA teams to design system requirements;
Work on the RTM document to show traceability between business requirements and system requirements;
Take a part in the ClinCheck Clinical Risk Assessment process and create Safety requirements where it’s needed.

In this role, you’ll need …

Fluent in English with excellent verbal and written communication skills.
Strong technical writing skills to gather and document system requirements clearly.
Proven understanding of development processes and agile methodologies (SCRUM).
Analytical and solution-oriented mind, critical and logical thinking, ability to reach the correct conclusion based on the available facts and arguments
Effectively coordinates work and communication across different groups of individuals and levels in the organization.

Additional Requirements

Good knowledge of Confluence/Jira, Word, Excel, PowerPoint and desire to learn new applications.
Experience and desire to learn 3D CAD systems in ortho, desire to become expert in this field.
Bachelor’s degree or higher in the SW, IT-related field.
Knowledge of any programming language is a plus.

Apply:

https://jobs.aligntech.com/jobs/28955

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