Principal Consultant

Emploi pas sur LinkedIn

🕒 il y a 16 jours

🏈 Alabama, California, +3 états de plus – Distant

🏈 Alabama – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🦌 Connecticut – Remote 🌽 Illinois – Remote

⏰ Temps Plein

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💼 Consultant

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ToxStrategies, a BlueRidge Life Sciences Company

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2008

💼 Conseil

🏥 Santé

🍽️ Alimentation et boissons

💰 Venture Round - ToxStrategies en 2023-01

Consulting • Healthcare • Food & Beverage

ToxStrategies est un cabinet de conseil scientifique multidisciplinaire et une entreprise de BlueRidge Life Sciences qui offre des services en toxicologie, sciences environnementales et sciences réglementaires à des clients de l'industrie, du gouvernement et du secteur juridique. L'entreprise propose une expertise en évaluation des risques, évaluation de l'exposition, toxicologie computationnelle, biodisponibilité, PFAS, micro- et nanoplastiques, sécurité alimentaire et pharmaceutique, dispositifs médicaux, méthodes alternatives (NAMs), épidémiologie, et conformité réglementaire (par exemple, TSCA, FSMA, Proposition 65). ToxStrategies soutient la gérance de produits, l'assistance en litige et la toxicologie basée sur des preuves dans le cadre de produits de consommation, de produits chimiques et de contextes biopharmaceutiques.

Description

• Participate in the project management and technical work of combination product development and support clients in bringing life-saving therapies to patients. • Lead technical discussion for internal and client teams as a technical subject matter expert on the development of drug delivery systems • Align program execution with industry standards, external regulatory requirements and site quality management systems • Develop design control deliverables to document compliance to medical device development processes • Prepare detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria • Establish and maintain project timelines and deliverables and maintain accountability for project budgets and program execution.

🎯 Exigences

• 10+ years as Principal or Sr. Principal systems engineer, technical lead, or equivalent experience in the development of combination products and/or medical devices. • BS in Engineering, Biology, Physics or related Scientific discipline • Master’s degree in Engineering, Biology, Physics or related Scientific discipline is desired. • Technical management of programs in both direct or matrix reporting organizations, coordinating and leading multiple team members through the execution of program deliverables. • Experience with the total lifecycle management of medical device programs, with preferred experience in the clinical and commercial development of drug delivery systems (combination products) • Direct experience developing design history file documentation in quality management systems, including Design and Development Plans User needs Requirements Risk management Verification Validation Design Transfer • Experienced in leading technical discussion for internal and client teams as a technical subject matter expert on the development of drug delivery systems • Preferred that candidate has pharmaceutical-related medical device experience on combination products and/or drug delivery systems • Understanding of DHF elements, and their integration through the medical device development process. • Thorough understanding of medical device processes: Design Controls (21 CFR 820.30) ISO13485 ISO14971 • Preferred SOP Writing and Review • Experience with, as well as experience and flexibility to work under a number of different quality management systems • Preferred, experience supporting regulatory teams in the authoring of regulatory submissions • Highly preferred, Experience with project management • Experience with one or more Autoinjectors, Pre-filled syringe, or on-body delivery systems is a plus

🏖️ Avantages

• Health insurance • Professional development • Flexible work arrangements