Senior Business Analyst with Device Traceability/Lifecycle Management experience (Contractor)

Binariks is looking for a highly motivated and skilled Senior Business Analyst Device Traceability/Lifecycle Management experience for a part-time assignment (Contractor).
As an important part of the project, you'll be responsible for:
- Device Lifecycle Tracking: Ensuring the traceability of medical devices across their lifecycle, including manufacturing, repair, and component sourcing
- Product Code Management: Addressing complexities in identifying products due to varying product codes across different markets and stakeholders
- Workflow Automation: Simplifying manual and fragmented processes (e.g., document searches, phone calls) for retrieving device history and traceability data.
- Search and Usability: The requirement for an intuitive search-based system is akin to "Google search" for data access.

What We’re Looking For:

Proven experience as a Business Analyst: 5+ years

1+ year of experience with Device Traceability/Lifecycle Management

1+ year of experience with Quality Management System (QMS)

Experience working in the healthcare industry

Knowledge of FDA regulations and standards for medical devices

Strong written and verbal communication skills, including technical writing skills

Excellent communication and collaboration skills

Upper-Intermediate or higher level of English

Your Responsibilities:

Conducting meetings with stakeholders to gather requirements, understand pain points, and facilitate discussions that lead to a comprehensive understanding of business needs

Collaborating with cross-functional teams, including developers and architects, to design solutions that address the identified business problems and align with the client's goals

Creating concise and clear documentation summarizing the results of business analysis activities

Presenting findings and proposed solutions to both technical and non-technical stakeholders in a way that is understandable and aligned with business goals