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| Associate Director QA/RA NC Open (J#27572) Education: Bachelors Degree Experience: 10 - 20 years Associate Director QA/RA This position will enhance existing in-house regulatory affairs, must have quality assurance expertise, and support the growing number of related business initiatives from a QA/RA position. This role offers a challenging opportunity to work with a highly skilled work force and to support them in understanding the regulations and requirements as needed for medical device components manufactured under ISO 13485:2003 and FDA QSR. Job Qualifications/Responsibilities: Bachelors degree in biology, microbiology, chemistry, chemical engineering, or related scientific field. 7-10 years experience in a Medical Device manufacturing environment in the quality assurance or regulatory area. Experience with US Class II / Class III medical devices or FDA regulations. Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports. Expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement. Experience in Quality systems maintenance; fully comprehends the cGMP, ISO 13485, and regulations pertaining to medical devices. Maintains and oversees the adherence of departmental Standard Operating Procedures, Quality System Procedures (QSP) manual, etc. Responsible for leading the continuous maintenance of the Quality System. Ability to maintain files and keep documentation updated and inspection ready. Proven track record in performing external and internal audits. Responsible for driving exceptional product quality for the customer and patient. Responsible for product release Qualifications, Validations, Protocols, Design Change management. Participates in the selection/approval of suitable suppliers and contractors, including but not limited to auditing potential and current suppliers to assure compliance with cGMP. Responsible for working with Customers QA to resolve product related issues quickly and effectively. Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities. Experience in Master Files beneficial but not required. Drug Screening, Post-offer Physical Examination & Criminal Background Search Required No agencies please. EOE and Drug-Free Workplace. | |||
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