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Regulatory Compliance & Quality Assurance Specialist, Moscow





Moscow, Russian Federation 

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**PURPOSE OF THE JOB:** + Identification and interpretation of local legislation covering RC&QA requirements + Post Marketing Surveillance and Reporting to the Competent Authorities + Establish and maintain Competent Authority Relationships + FSCA/FSN/Recall coordination + Establish and maintain Quality System elements aligned with Abbott requirements **KEY RESPONSIBILITIES:** + Identify and communicate on local regulations + Analyze regulations and suggest business-oriented solutions + Represent Abbott in trade/government associations + Coordinate and monitor product experience/complaint + Ensure compliance in reporting product experiences according to Abbott requirements + Submit reports to Competent Authorities in the region + Coordinate answers to Competent Authority questions + Build and maintain strong relationships with Competent Authorities + Participate in local and regional trade associations + Implement and maintain quality system elements (purchasing control incl. suppliers and distributors, CAPA, document control, audits, warehouse control, training, stop ships, quality metrics etc.) + Authoring procedures to adapt quality system procedures as necessary locally + Organize and present Management Review Meetings + Ensure compliance with applicable local regulations, as well as Abbott policies and procedures + Report on quality system needs to AMIO + Provide regulatory compliance and quality system training to employees and distributors + Ensure compliance in performing the training as required by the training procedure **EDUCATION & COMPETENCIES:** + Higher education in engineering field. + Knowledge of ISO 13485, ISO 9000 is desirable. + Analytical skills and detail oriented. + Good organization, planning, verbal and written skills. + Strong interpersonal skills, with the ability to build and maintain relationships. + Comfortable and efficient in a matrix environment and interfacing with different international sites and business units. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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Abbott Ireland
Cashel Road
Co Tipperary, Ireland
Phone: 00353 52 6173562
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