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Regulatory/Quality System Sr. Specialist

Laboratory Corporation of America Holdings (Covance)

Minneapolis, Minnesota, United States

Job Overview:

We are hiring a Regulatory/Quality System Specialist in our Minneapolis, MN office. 

This role will provide direction and leadership to clients in the development and implementation of regulatory strategies to ensure timely global commercialization of new and devices, in compliance with applicable regulations and standards (US and international)..  Ensures compliance with applicable national and international regulations and standards during all phases of the product life cycle. The Regulatory/ Quality System Specialist will direct the development and implementation of systems for the preparation of quality submissions, which meet regulatory requirements to ensure timely device approval and maximize market opportunities. Assists clients in the development of documentation designed for FDA, Competent Authorities, Notified Bodies, and other related regulatory authorities. Assists in regulatory inspections, field corrective actions, post market surveillance, patient registration, device tracking, complaint reporting and MDR and vigilance reporting activities, and other Quality Management Systems related activities as required. Supports the development and implementation of product development, manufacturing and strategic operating plans. Establishes project timelines/schedules. Interacts with clients and potential clients, as appropriate. Represents and assists in the marketing of Covance capabilities and services throughout the medical device product industry and related affiliations.Other duties as assigned.      

  Education/Qualifications:

Bachelor’s degree plus four or more year’s applicable experience with medical devices or regulatory agency.  Advanced technical degree with at least 2 years’ experience. Experience:Knowledge of FDA regulations and four or more year’s device submission experience. FDA or EU compliance experience preferred. Knowledge of Quality Management Systems Project management experience preferred. Ability to comprehend the engineering principles, clinical, and physiological aspects of medical devices. Effective oral and written communication skills. Effective interpersonal skills. Strong organizational skills and detail-orientation. Demonstrated abilities to communicate cross-functionally throughout organizations. Familiarity with basic computer applications, e.g., Word, PowerPoint.

Job posted: 2020-07-15

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