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Vice President Regulatory Affairs Quality Assuranc

Company: HealthCare Recruiters International
Location: Lompoc
Posted on: June 19, 2022

Job Description:

Location:Lompoc, CA 93436Job TypeFull-Time RegularPosition CategoryMedical DeviceDate Posted11/29/2021Great opportunity to join a long-standing dental manufacturer as Vice President of Regulatory Affairs and Quality Assurance.The right candidate will be willing to relocate to Central California (not far from Santa Barbara). The functions of the position are as follows ...* Coordinate activities to ensure compliance with all applicable regulatory requirements and achievement of company objectives as well as resolve problems. * Plan and direct the organization's Quality Systems and Regulatory policies, objectives, and initiatives.* Plan, direct and document the review of the suitability, effectiveness and adequacy of the organization's Quality System.* Manage the Quality Assurance Program in accordance with FDA Quality System Regulations (QSRs) and ISO 13485 Quality Systems. Serve as the Company's Management Representative and Person Responsible for Regulatory Compliance (PRRC), and be the lead contact for all regulatory agencies, notified bodies, and international representatives, including but not limited to MDSAP and EU-MDD/MDR countries.* Develop, implement and maintain processes used in the design, manufacture, and service of devices and assure that they are adequate, in support of and aligned with company objectives and in full compliance with regulatory requirements.Education and/or ExperienceBachelor's degree (B.S.) from four-year college or university; and ten years as a senior manager with quality assurance and/or regulatory experience in manufacturing medical devices; or equivalent combination of education and experience. Advanced degree and experience in the medical device manufacturing quality assurance area preferred. Knowledge of MDR vs. MDD.

Keywords: HealthCare Recruiters International, Lompoc , Vice President Regulatory Affairs Quality Assuranc, Executive , Lompoc, California

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