Bannick LLC is extremely pleased to welcome Stefanie Martinez Koenig, who joins us as the Director of Clinical and Regulatory Affairs this last May. She is a key member of our Executive Team; tasked with providing overall program leadership and management of our regulatory affairs, including medical writing, and clinical affairs groups. She looks forward to partnering closely with clients to identify their needs, resolve any issues and ensure on time service delivery.
Stefanie is a results-driven executive with more than 25 years of experience working in quality assurance and regulatory affairs for the device, pharmaceutical, and biopharma sectors. She is a strategic change-agent with proven accomplishments and has been recognized for developing creative and extraordinary partnerships to meet business objectives. She brings to the Bannick team strong experience in quality systems and auditing, MDD to MDR transition, regulatory and clinical affairs.
Stefanie has a BS in Microbiology and MS in Operations and Technology Mgmt. She is an active member of RAPS and ASQ, an ASQ certified Quality Engineer (CQE) and Certified Quality Manager in Operational Excellence. #regulatoryaffairs #leadership #medicaldevices #clinicalresearch #biopharma #clinical #pharmaceutical #auditservices