Edward Spence

Background

About Edward Spence

Experienced Senior Project Manager with a proven track record of leading cross-functional teams across the medical device, pharmaceutical, healthcare, automotive, and telecommunications industries. I bring over a decade of expertise managing complex product development programs from concept through commercialization, including regulatory submissions such as IND, NDA, 510(k), and PMA. Certified in PMP, Scrum, and Six Sigma, I specialize in aligning diverse stakeholders, navigating regulatory frameworks (FDA, EMA, ISO 13485, ICH-GCP), and driving projects to successful, on-time completion. Whether launching a new device, managing clinical trials, or coordinating with global teams and vendors, I maintain a focus on strategic execution and compliance throughout every phase. Known for my composure under pressure, keen attention to detail, and ability to build trust across departments, I am passionate about delivering meaningful healthcare innovations—done right. Let’s connect if you’re interested in collaborating on complex initiatives or exchanging ideas about effective leadership and execution in regulated industries.