Hybrid MedTech Business Analyst – Regulatory & 510(k) Focus

Hydrogen Group; Motherwell; Hybrid; GBP 94,000 - 103,000; Full time

Job summary

Hydrogen Group is seeking a hands-on Business Analyst for a UK-based project team in the medical device sector, located in Motherwell with hybrid working. The role focuses on supporting a 510(k) submission and the commercial release of an updated software version.

Key requirements include medical device regulatory knowledge, hands-on BA experience, and proficiency with Jira, Jama, Confluence, Lucid and Miro, plus strong analytical and stakeholder management skills.

Qualifications

• Hands-on Business Analysis experience.
• Must have Medical device-specific regulatory knowledge.
• Experience using Jira, Jama and Confluence.
• Experience with Lucid and Miro for visual modelling.
• Good understanding of Agile and software delivery frameworks.
• Strong requirements gathering, analysis and documentation skills.
• Data analysis fundamentals.
• Strong analytical and logical thinking.
• Confident stakeholder management across business and technical teams.
• Pragmatic, critical-thinking approach focused on delivering value.
• High levels of initiative, adaptability and proactive ownership.

Responsibilities

• Support a UK-based project team in the medical devices sector.
• Contribute to the 510(k) submission process and subsequent software release phases.
• Engage with stakeholders across business and technical teams to gather and document requirements.

Skills

Business Analysis

Medical device regulatory knowledge

Stakeholder management

Requirements gathering

Data analysis

Analytical thinking

Critical thinking

Initiative

Proactive ownership

Agile delivery

Tools

Jira

Jama

Confluence

Lucid

Miro

Job description

Hydrogen Group is seeking a hands-on Business Analyst for a UK-based project team in the medical device sector, located in Motherwell with hybrid working. The role focuses on supporting a 510(k) submission and the commercial release of an updated software version.

Key requirements include medical device regulatory knowledge, hands-on BA experience, and proficiency with Jira, Jama, Confluence, Lucid and Miro, plus strong analytical and stakeholder management skills.