Key Responsibilities:

Requirements Gathering &amp; Analysis:

<ul>
<li style="margin-left:0px;">Work closely with product owners, business stakeholders, and end users to elicit and document business and functional requirements.</li>
</ul>

<ul>
<li style="margin-left:0px;">Translate business needs into clear and detailed user stories, process flows, and acceptance criteria.</li>
</ul>

Domain Expertise:

<ul>
<li style="margin-left:0px;">Leverage strong understanding of the medical devices industry, including regulatory standards (FDA, ISO 13485, IEC 62304, MDR, HIPAA).</li>
</ul>

<ul>
<li style="margin-left:0px;">Collaborate with R&amp;D, QA, and compliance teams to ensure that business processes and documentation align with domain regulations.</li>
</ul>

Product &amp; Solution Definition:

<ul>
<li style="margin-left:0px;">Contribute to defining product features and capabilities for software-enabled medical devices or healthcare solutions.</li>
</ul>

<ul>
<li style="margin-left:0px;">Support product validation, verification, and usability studies through business and functional inputs.</li>
</ul>

Stakeholder Management:

<ul>
<li style="margin-left:0px;">Act as a liaison between business teams, technical developers, and QA to ensure alignment of requirements and deliverables.</li>
</ul>

<ul>
<li style="margin-left:0px;">Conduct regular review sessions, demos, and feedback meetings with internal and client stakeholders.</li>
</ul>

Documentation &amp; Communication:

<ul>
<li style="margin-left:0px;">Prepare comprehensive documentation such as BRDs, FRDs, user stories, process maps, and traceability matrices.</li>
</ul>

<ul>
<li style="margin-left:0px;">Maintain version control and audit trail of all requirement artifacts in compliance with medical device documentation practices.</li>
</ul>

Process Improvement:

<ul>
<li style="margin-left:0px;">Identify opportunities for process optimization and contribute to continuous improvement initiatives in requirement management and delivery. </li>
</ul>
Required Skills &amp; Experience:

<ul>
<li style="margin-left:0px;">6+ years of total experience as a Business Analyst, with at least 3 years in the medical devices or healthcare domain.</li>
</ul>

<ul>
<li style="margin-left:0px;">Proven experience in requirements management, functional documentation, and stakeholder communication.</li>
</ul>

<ul>
<li style="margin-left:0px;">Strong understanding of medical device product lifecycle, including concept, design, validation, and post-market phases.</li>
</ul>

<ul>
<li style="margin-left:0px;">Knowledge of regulatory standards such as FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971 (Risk Management).</li>
</ul>

<ul>
<li style="margin-left:0px;">Experience with software development methodologies (Agile/Scrum).</li>
</ul>

<ul>
<li style="margin-left:0px;">Hands-on experience with tools like JIRA, Confluence, MS Visio, Figma, or similar platforms.</li>
</ul>

<ul>
<li style="margin-left:0px;">Excellent verbal and written communication skills, with the ability to convey technical concepts to non-technical stakeholders. </li>
</ul>
Preferred Qualifications:

<ul>
<li style="margin-left:0px;">Bachelors or Masters degree in Engineering, Biomedical, Life Sciences, or related fields.</li>
</ul>

<ul>
<li style="margin-left:0px;">Certification in Business Analysis (e.g., CBAP, CCBA, or PMI-PBA) is a plus.</li>
</ul>

<ul>
<li style="margin-left:0px;">Prior experience working on connected medical devices, diagnostic instruments, or digital health solutions will be highly desirable.</li>
</ul>

Key Attributes:

<ul>
<li style="margin-left:0px;">Detail-oriented with strong analytical and problem-solving skills.</li>
</ul>

<ul>
<li style="margin-left:0px;">Self-driven, proactive, and capable of managing multiple priorities.</li>
</ul>

<ul>
<li style="margin-left:0px;">Ability to work in cross-functional and multi-cultural environments.</li>
</ul>

Technical Business Analyst

Key Responsibilities: Requirements Gathering &amp; Analysis: Work closely with product owners, business stakeholders, and end users to elicit and document business and functional requirements. Translate business needs into clear and detailed user stories, process flows, and acceptance criteria. Domain Expertise: Leverage strong understanding of the medical devices industry , including regulatory standards (FDA, ISO 13485, IEC 62304, MDR, HIPAA). Collaborate with R&amp;D, QA, and compliance teams to ensure that business processes and documentation align with domain regulations. Product &amp; Solution Definition: Contribute to defining product features and capabilities for software-enabled medical devices or healthcare solutions. Support product validation, verification, and usability studies through business and functional inputs. Stakeholder Management: Act as a liaison between business teams, technical developers, and QA to ensure alignment of requirements and deliverables. Conduct regular review sessions, demos, and feedback meetings with internal and client stakeholders. Documentation &amp; Communication: Prepare comprehensive documentation such as BRDs, FRDs, user stories, process maps, and traceability matrices. Maintain version control and audit trail of all requirement artifacts in compliance with medical device documentation practices. Process Improvement: Identify opportunities for process optimization and contribute to continuous improvement initiatives in requirement management and delivery. Required Skills &amp; Experience: 6+ years of total experience as a Business Analyst , with at least 3 years in the medical devices or healthcare domain . Proven experience in requirements management , functional documentation , and stakeholder communication . Strong understanding of medical device product lifecycle , including concept, design, validation, and post-market phases. Knowledge of regulatory standards such as FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971 (Risk Management). Experience with software development methodologies (Agile/Scrum) . Hands-on experience with tools like JIRA, Confluence, MS Visio, Figma, or similar platforms . Excellent verbal and written communication skills, with the ability to convey technical concepts to non-technical stakeholders. Preferred Qualifications: Bachelors or Masters degree in Engineering, Biomedical, Life Sciences, or related fields . Certification in Business Analysis (e.g., CBAP, CCBA, or PMI-PBA) is a plus. Prior experience working on connected medical devices, diagnostic instruments, or digital health solutions will be highly desirable. Key Attributes: Detail-oriented with strong analytical and problem-solving skills. Self-driven, proactive, and capable of managing multiple priorities. Ability to work in cross-functional and multi-cultural environments.

Technical Business Analyst in Chennai (UID-14637)

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Job Description for Technical Business Analyst

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