Head of Quality & Regulatory

Summary

Experienced regulatory and quality professional with 20 years experience in the medical device, IVD, life sciences, and pharmaceutical sectors. Proven success in MDR transitions, QMS implementations (ISO9001, ISO13485), and audit management. Skilled in strategic regulatory and business alignment, risk-based approaches, and team leadership. Has delivered academic and industry training in quality, regulatory and process management.

Expectations

Seeking a role to challenge and utilise my skills, for the benefit of a new organisation. I am experienced in very large multi-site organisations as well as very small, single digit employee companies, and am able to adapt approaches in line with expectations for these.

Employment Preferences

Expected Base Salary

**8,000 USD

Expected Hourly Rate

** USD/hr

Experience

Skills

• ISO9001
• ISO13485
• ISO14971
• Audit Management
• QMS
• Regulatory Affairs
• Risk Management
• Complaints
• Problem Solving
• Training
• Quality Management
• Team Leader