Heidi Strunk

Background

About Heidi Strunk

Regulatory and quality professional with extensive experience in the medical device, in vitro diagnostic (IVD) and life sciences industries on a global scale. Energetic, approachable leader with strong work ethic and hands-on attitude. Proven track record of successful results, with over thirty-five years experience in FDA-regulated industries, including thirty years in management. Breadth of experience spans large companies to hyper-growth start-ups, mergers/acquisitions, FDA warning letter remediation, certifications to IVDR, MDSAP, & UKCA, and facility moves. Strengths include: technical expertise, creating systems and processes, managing transitions, building relationships, establishing trust, and developing others. • Certified Regulatory Affairs Professional (RAC) • Medical Device & IVD expertise • IVDD, IVDR and UKCA certifications • MDSAP and ISO 13485 certifications • FDA QS Reg / GMP / ISO expert • Warning Letter Remediation • Quality System design • Regulatory Submissions • System/process creation/improvement • Process / Continuous Improvements • Change Management / Transitions • Excellent Interpersonal Skills