Trevor Wright Email and Phone Number
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International Regulatory Affairs Director with an incredible record of market penetration and expansion of novel and existing medical devices, blood, tissue and biologics products globally. A demonstrated leader and subject matter expert in regulatory compliance, quality assurance and domestic as well as, foreign standards and regulations as evidenced by global market growth for clients.
Allosource®
View- Website:
- allosource.org
- Employees:
- 333
-
Director Of Regulatory AffairsAllosource® May 2017 - PresentColorado, United StatesPromoted 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. -
Regulatory Affairs ManagerAllosource® May 2013 - Apr 2017Colorado, United StatesPromoted 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. -
Sr. Regulatory Affairs SpecialistAllosource Feb 2011 - May 2013Coordinated 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. -
International Regulatory Affairs SpecialistTerumo Blood And Cell Technologies 2008 - 2011Operated 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. -
Regulatory Affairs SpecialistVitalant 2005 - 2008Performed 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. -
Quality Systems SpecialistTerumo Blood And Cell Technologies 2002 - 2005Served 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. -
Staff ScientistDynamac, Inc. 1999 - 2002Served 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. -
Hillside Agriculture ExtensionistPeace Corps 1996 - 1998Honduras, Central AmericaRecruited 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.
Trevor Wright Education Details
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Biology, Minor In Chemistry
Frequently Asked Questions about Trevor Wright
What company does Trevor Wright work for?
Trevor Wright works for Allosource®
What is Trevor Wright's role at the current company?
Trevor Wright's current role is Regulatory Affairs Director with international scope and subject matter expert in regulatory compliance.
What is Trevor Wright's email address?
Trevor Wright's email address is tw****@****rce.org
What schools did Trevor Wright attend?
Trevor Wright attended Linfield University.
Who are Trevor Wright's colleagues?
Trevor Wright's colleagues are Eric Bis, Dragana Avirovik-Nooney, Mary Pirello, Caleb Essick, Dan Vercande, Ryan Hu, Jan Hamilton.
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