Caroline Alexander

WORK HISTORY

EDUCATION

SKILLS

ABOUT CAROLINE ALEXANDER

Over 20 years of experience in Quality and Regulatory Affairs across multiple healthcare-related industries including Pharma, laboratory testing, and IVD medical devices specifically Near-Patient Tests (or Point of Care). • Currently responsible for leading Quality Assurance, Quality Control, Product Risk Management, and Regulatory Affairs for an IVD medical device manufacturer.• Recruited and trained a team of 18 staff in total; 4 managers (direct reports) and a further 14 team members across four disciplines.• As a member of the Senior Leadership Team, I report to the CEO, make company-wide decisions and set company policy and strategy.• Budget holder and controller setting salary and bonus levels for a team of 18 people reviewing and contributing to agreement on company-wide bonus structure.• Directly manage remote and office-based personnel across diverse departments.• Contribute to commercial strategy on geographic expansion to increase sales revenue.• Excellent communication skills; experienced in delivering presentations to whole company, Senior Leadership Team and Board members.• Maintain an accurate view of the changing global regulatory landscape.• Designated PRRC and UK RP.• Successful submissions made globally with approvals and registrations in: UK, KSA, Belgium, France, Italy, Greece and Qatar with applications underway with US FDA and SFDA.• Familiar with WHO PQ, WHO EUL, US EUA and MHRA derogation for emergency use pathways.• Significant experience in IVDD, MDD, MDR, IVDR, GAMP 5, 21CFR820 and standards including ISO 13485, ISO 14971, ISO 62366, IEC 62304, ISO 20916 and ISO 23640.• Zero non-conformities arising from external (3rd party) audits for 3 consecutive years.• Experienced mentor and supporter of women in leadership roles.I am also co-founder of Astro Ventures; a CIC committed to facilitating an understanding of astronomy through outreach, stargazing workshops and holidays & breaks in Northumberland Dark Sky Park, based at the Dark Sky Observatory at Battlesteads Hotel in Wark, Northumberland.