Trevor Wright Email & Phone Number

Colorado, United States

Promoted to a senior leadership position overseeing 10 professional roles of Regulatory Affairs Specialists, Quality System Auditors and Engineers having a global scope of impact for a company with $160M in revenue. Directs the regulatory affairs function critical to operations and financial growth of the company, enabling avoidance of costly compliance/risk/quality issues and expanding penetration of products into new and existing markets, requiring compliance with a variety of diverse regulations, accreditation and licensure requirements. Develops and manages relationships with regulatory, accreditation and standards organizations to ensure compliance and expedite product disbursement. Collaborate across international teams and diverse functions, including liaising with executive management to drive regulatory compliance.

Colorado, United States

Promoted from a senior specialist to manager within two years to oversee a team of six staff to drive regulatory strategies for new and existing human tissue and medical device products. Role included management of quality metrics, regulatory licensure, registration systems, adverse reactions, event reporting and complaint handling. Liaised with executive management to address regulatory compliance issues and serve as a trusted advisor for purposes of resource allocation, quality assurance, planning and budgeting. Guided staff in regulatory matters and effective collaboration across marketing, R&D and operations departments to ensure and expedite regulatory conformance requirements and pre-market clearances, enabling expansion of product markets.

Coordinated with international regulatory departments and staff to support worldwide regulatory planning and deliverables for the market penetration of new and existing products, as well as necessary design changes. Resolved complex regulatory issues unique to each market and unique to human tissue, medical devices and biologic products. Responsibilities included development, implementation and maintenance of procedures in support of regulatory compliance, project and/or product and process improvements that enabled efficient operations and regulatory acceptance of products across global markets.

Operated as an International Regulatory Affairs Specialist for Gambro, now Terumo. Drove global market expansion and sales of new and existing products in the amount of $100M in three years, through establishment of regulatory plans that complied with each international market’s regulatory requirements for blood cell technologies. Coordinated and collaborated with a diverse team of professionals including regulatory affairs staff, engineers, technical experts, foreign governments and Food and Drug Administration to anticipate and design global market submission strategies to smooth approval processes and mitigate costly challenges, while enabling market introduction and expansion of products.

Performed as a Regulatory Affairs Specialist for Bonfils Blood Center, now Vitalant. Served as an internal consultant, advising senior leadership on the components necessary to receive FDA approvals and drive operational quality improvement, compliance and regulatory initiatives. Initiatives included development of current good manufacturing practices, monitoring product recalls, preventive action systems, auditing of practices against accrediting agency regulatory standards and laboratory proficiency testing and compliance.

Served as a regulatory resource and advisor for a donor testing laboratory by providing expert implementation and improvement of quality systems such as auditing, records management, labelling of products and processes, testing procedures, error management, donor eligibility and recalls according to FDA regulations, all vital to laboratory operations and business viability.

Served as a technical contractor, supervising a staff of 12 research assistants and interns, training each on procedures, assigning goals, assessing compliance with FDA procedures and more for purposes of determining the health of eco-systems and inform legislation promoting a local, state and national healthy environment. The work promoted a balance between environmental safety and sustainability with the goals of industry, through managing extensive and complex ecological modeling and research projects.

Honduras, Central America

Recruited to lead the assessment and planned development of a farming community in Central America to include articulating the project objectives and related strategies, utilizing local and international funding and resources. Administered grant funding, logistics, training and facilitation of meetings and events, while driving the continuation and development of the project to success.