Posted on: November 11, 2018
Compliance/Audit Specialist Location: Jacksonville, Florida, United States Requisition #: 18000J0E Post Date: 6 hours ago **Careers that Change Lives** Are you a passionate, dedicated and motivated **Compliance Audit Specialist** that will thrive in role the conducts and reports on internal audits of Medtronic facilities worldwide to determine the state of compliance to appropriate regulations and standards, corporate policies and expectations, Corporate and local (site specific) procedures and policies? As a **Compliance Audit Specialist** you will be responsible to facilitate internal and external audit/inspection corrective and preventive actions, track completions and verify the effectiveness of the actions as well as to evaluate overall data for trends and recommend systemic action at a business-wide level. Come for a job, stay for a career. **A Day in the Life** Responsibilities may include the following and other duties may be assigned. + Performs the coordination and/or preparation of internal and external audits and compliance in accordance with regulatory standards (includes FDA and its equivalents outside the US as well as other government regulatory agencies / authorities). + Interprets government regulations as they apply to products, processes, practices and procedures. + Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met. + Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc. + Analyze audit data and present findings to management, support Corrective Action Plans, and provide coaching to business partners. + Assist in managing recalls and field actions. + Develop and implement programs designed to increase employee awareness and knowledge of compliance policies. **Must Have: Minimum Requirements** Education: ?B.S./B.A. degree Experience: ?2+years of regulatory/quality/compliance experience with a Bachelor?s degree or 0+ years of regulatory/quality/compliance experience with a Master?s degree. **It would be ideal if you also had the following experience:** ?Auditing experience to worldwide quality, clinical, regulatory requirements. ?Experience in life science or related fields such as the regulated device industry preferred. ?Understanding and application of the quality system requirements (i.e. FDA 21 CFR 820, 803, 806, ISO 13485, European Medical Device Directive, CMDCAS, PAL/Japan GMP) and relevant standards for medical device/combination device industry. ?Must understand pragmatic approaches to regulations, as well as intent of regulations. ?Experience working with regulators worldwide. ?Knowledge of ISO 14971 and risk management tools. ?Knowledge of statistical methods and quality tools. **About Medtronic** Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let?s work together to address universal healthcare needs and improve patients? lives. Help us shape the future. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Keywords: Medtronic, Jacksonville , Compliance/Audit Specialist, Accounting, Auditing , Jacksonville, Florida
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