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Senior Quality and Regulatory leader with over 20 years of experience in the medical device and biotechnology industries. Provider of regulatory expertise and guidance to global companies for Class I, II, and III medical devices and cellular tissues for drug development and therapeutics. Exceptional work ethic, communication skills, and leadership ability. I am passionate about ensuring the safety and effectiveness of innovative products and services that improve the lives of patients and customers. I also have a strong background in engineering, product development, and project management, which I have leveraged throughout my career to provide in-depth analysis and ensure product and strategic goals were met. I am a collaborative and strategic leader who is able to work across different functional levels and departments to bring about positive results both operationally and in production environments.
Stealth Medical Device Startup; Evolutions Aba Inc.
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Quality And Regulatory Consultant; Healthcare Administrator And Co-FounderStealth Medical Device Startup; Evolutions Aba Inc.San Clemente, Ca, Us
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Director, Quality And Regulatory | EhsÖssur 2019 - 2024Reykjavik, Iceland, IsResponsible for setting and implementing the Quality & Regulatory vision and direction for the Össur Americas region, accounting for 49% of global sales. Q&R Partner for the Bracing and Supports strategic business unit, ensuring global quality and regulatory compliance for the Class I and Class II product portfolio, accounting for 37% of global product sales. Provider of quality and engineering standards for the development and implementation of new products, processes, and strategic business plans. Oversight of all filings and communication with notified bodies and regulatory authorities, including BSI (ISO 13485:2016, MDR, ISO 14971:2019), FDA, Health Canada, and TGA. Responsible for ensuring all M&A and white label due diligence projects meet company and regulatory standards. -
Senior Qa Project ManagerAbbott 2018 - 2019Abbott Park, Illinois, UsResponsible for ensuring all processes and products across a medical device manufacturing site were in compliance with the new In Vitro Diagnostic Medical Device Regulation (IVDR). Accountable for creation and maintenance of the project plan; adherence of the quality management system and technical files to global regulatory requirements; and facilitating cross-functional development activities. -
Head Of QualityOrganovo Holdings, Inc. 2013 - 2017San Diego, California, UsDeveloped, implemented, and maintained a company-wide quality management system designed to enable, and resulting in, the successful commercialization of Organovo’s bioprinted tissues and associated services. Established and led the Organovo quality team, ensuring a discipline and culture of quality throughout the company. Ensured document control, management review, training, post-market surveillance, auditing, risk assessment, root cause investigation, and CAPA programs were established and followed. Also actively participated in Organovo product development activities, providing product and project management expertise to the ExVive Human Liver and Kidney Tissue programs. Supported production and operations team in establishment and maintenance of Class 10,000 clean room and associated activities. -
Quality And Operations ConsultantNathan Wildgrube, Inc. 2009 - 2013Worked closely with startup companies, including biotech, medical device, manufacturing, wholesale, and retail establishments, developing internal systems and tracking metrics to ensure successful management of manufacturing projects, inventory, and cash flow. Also established quality control processes to ensure products and services were delivered successfully and to the satisfaction of customers (both internal and external). Assisted with the regulatory strategy of an AI pathology laboratory developed test (LDT).Clients included Reveal Biosciences, Organovo, StressEraser, Purl Soho, Bogobrush, and GNP Frame.
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Director, Quality And OperationsStresseraser 2003 - 2009Responsibilities included management of all logistical details related to regulatory compliance, product development, quality assurance, manufacturing, and customer service. This includes establishment of a quality and documentation system that adhered to FDA and ISO 13485 regulations; creation of product requirements, specifications, and validation documentation; and oversight of the post market surveillance program.
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Product Manager, Netcool/PrecisionMicromuse, Inc. 2001 - 2003Gathered all technical and sales requirements for the company's discovery and root cause analysis software product, ensuring that customer needs and marketing demands were properly represented.Created, presented, and managed the product technical message, ensuring that it was adhered to by the sales and engineering teams.
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Team Lead, Networking TechnologiesMicromuse, Inc. 2001 - 2003Led a team of five networking technology engineers who specialized in highly complex installations and pre-sales presentations of networking software at high profile global companies. Performed and oversaw the technical due diligence for the $64 million acquisition of Riversoft, a publicly traded networking management company.
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Product SpecialistMicromuse, Inc. 1999 - 2001Acted as the last point of escalation for the global technical services team, providing sales, installation, and technical support as needed. Assisted in the creation of all engineering field documents and provided editorial assistance for all user documentation.
Nathan Wildgrube Skills
Nathan Wildgrube Education Details
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The Cooper Union For The Advancement Of Science And ArtMechanical Engineering
Frequently Asked Questions about Nathan Wildgrube
What company does Nathan Wildgrube work for?
Nathan Wildgrube works for Stealth Medical Device Startup; Evolutions Aba Inc.
What is Nathan Wildgrube's role at the current company?
Nathan Wildgrube's current role is Quality and Regulatory Consultant; Healthcare Administrator and Co-Founder.
What is Nathan Wildgrube's email address?
Nathan Wildgrube's email address is wi****@****ail.com
What is Nathan Wildgrube's direct phone number?
Nathan Wildgrube's direct phone number is +191786*****
What schools did Nathan Wildgrube attend?
Nathan Wildgrube attended The Cooper Union For The Advancement Of Science And Art.
What skills is Nathan Wildgrube known for?
Nathan Wildgrube has skills like Product Management, Integration, Management, Start Ups, Product Development, Pre Sales, E Commerce, Enterprise Software, Saas, Business Planning, Cloud Computing, Solution Architecture.
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