Nathan Wildgrube Email & Phone Number

San Clemente, CA, US

Reykjavik, Iceland, IS

Responsible 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.

Abbott Park, Illinois, US

Responsible 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.

San Diego, California, US

Developed, 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.

Worked 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.

Responsibilities 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.

Gathered 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.

Led 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.

Acted 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.