Expert Details
Software - Quality Assurance, Regulatory Affairs and Licensing
ID: 730387
United Kingdom
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1982 | Degree: NDip (BSc equivalent) | Subject: Automation and Instrumentation | Institution: Halton Technical Institute |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2008 to 2011 | Employer: Swiss Precision Diagnostics | Title: Software Quality Assurance | Department: |
Responsibilities:Responsible for SQA for product and manufacturing/consumer care and other supporting software |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2011 to Present | Agency: Enterprise Ireland | Role: Regulatory Strategist | Description: Developed Regulatory strategy for a number of 'Spin-out' companies |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: to Present | Country / Region: USA and Puerto Rico | Summary: Software Quality Assurance for clients throughout USA and Puerto Rico |
| Years: to Present | Country / Region: Mainland Europe | Summary: Software Quality Assurance for clients throughout Europe |
| Years: to Present | Country / Region: Ireland | Summary: Software Quality Assurance for clients throughout Ireland |
| Years: 1999 to 2000 | Country / Region: Singapore | Summary: Software Quality Assurance for clients throughout Singapore |
Additional Experience
| Vendor Selection |
|---|
| PDA Software Vendor Auditor 1999; Have audited over 40 potential or actual vendors of software for clients |
| Marketing Experience |
|---|
| Have gained licenses for a number of medical devices that contain software. Have hosted or been on call for a number of audits that clients have been subjected to from regulatory authorities. Have been party to the removal of consent decree for clients. |
Fields of Expertise
embedded software, ISO 9000 implementation for software, ISO/IEC 12207 -- Software Life Cycle Processes standard, medical device software, medical software, medical software quality assurance, software certification, software documentation control, software life cycle, software quality assurance, software registration process, software validation, embedded software testing, embedded system software development, document management software, enterprise resource planning software, computer software technology innovation, CASE tool, application software, computer programming