Maritza Celaya Email & Phone Number

Miami Lakes, Florida

Directly reported to the Chief Medical Officer with complete responsibility for the Regulatory Affairs Department. Provided the organization and clinical team with clinical and regulatory guidance and support. Supported over 50 emergency and compassionate use cases. Selected and negotiated contracts for the European Authorized Representative and the European Notified Body. Led the company to gain IDE and CE mark approval. Initiated Establishment Registration and Device Listing. Managed the procurement of external suppliers and global in-country representatives.Responsible for regulatory strategic planning and departmental growth. Recruited, developed and managed a staff comprised of twelve employees. Led the regulatory team through its first PMA application and various clinical trials. Developed and maintained a successful relationship with our lead FDA reviewers and other regulatory agencies. Mentored new hires and existing staff; developed staff to leadership positions. Supported and provided expertise to expand product presence in more than 30 countries including commercial approvals in Brazil, Australia, Canada and Taiwan. Review and approve marketing promotional materials.

Miami Lakes, Florida

Responsible for providing regulatory support to the organization for the global development of medical devices while ensuring compliance with worldwide governmental agencies and corporate policies & procedures. Maintain current knowledge of federal regulations concerning regulatory requirements and strategies to create, prepare and achieve regulatory submissions, including 510(k), IDEs, HDEs, PMAs, Design Dossiers and Summary Technical Documents (STeD) for approvals in the US, EU, Japan, Canada, APAC, L.A. and other markets.

Miami Lakes Florida

Primary responsibility for the regulatory filings related to satisfying post-market conditions of approval for the CYPHER drug-eluting stent system, the first cardiovascular stent/drug combination product.

Miami, Florida

Managed the chemistry quality control department. Provided technical and marekting operational support for the clinical chemistry laboratory, immunoassay and specialty controls product lines to internal and external customers.

Bachelor Of Science (Bs) Degree, Clinical Laboratory Science/Medical Technology

State of Florida Department of Health, Division of Medical Quality Assurance, Clinical Laboratory Supervisor EU RAC Certified, Regulatory.

Bachelor Of Science (Bs)