Business Analyst

About the Role:

Business Analyst

Key Responsibilities:

• Requirements Gathering & 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&D, QA, and compliance teams to ensure that business processes and documentation align with domain regulations.

• Product & 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 & 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 & 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.