Sr. QARA Specialist

Sr. QARA Specialist (Technical Director) As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. The Latin America Region of Teleflex is headquartered in Morrisville, North Carolina, and supports our customers, distributors, sales managers and specialists in Mexico, Brazil, Colombia, Chile, Argentina and Puerto Rico. Position Summary The Sr. QARA Specialist supports Quality Assurance and Regulatory Affairs elements for Teleflex Logistics and Distribution Center within the country. Main activities include being the Technical Director to provide support on Technovigilance, local labeling processes, document control; quality systems training in accordance with internal procedures, external regulations, and international standards. Principal Responsibilities Quality Assurance function through the following activities: Supports global activities related to product, including resolution of regulatory and quality issues Serves on Regional and Corporate level teams as assigned Suggests and debates alternative methods and procedures for solving problems and meeting changing related to importation, storage, distribution and commercialization Ensures that product is stored according to correct storage conditions Develops initial and subsequent modifications to the product quality maintenance to delineate areas of responsibility, personnel requirements, and operational procedures within the program Evaluates contents of reports from quality assurance initiatives and confers with management personnel preparatory to revisions to product assurance program Reviews procedures of departments and recommends solutions to procedure changes Evaluates the non-conformances, providing a treatment and solution Confers with representatives of material and service vendors to obtain information related to supply quality, vendor capacity to meet requirements, and vendor quality standards Confers with Teleflex Manufacturing sites about quality assurance aspects of manufactured products Reviews technical publications, articles, abstracts, and standards to stay abreast of developments in the industry Coordinates and facilitates customer, corporate compliance, and regulatory/registration audit visits Prepares and submits required corporate reports concerning quality reporting and general regulatory compliance Maintains the internal audit system Maintains the calibration program of all measuring and test equipment used to accept product Oversees and ensures the documentation system is adequate for assigned sites Technical Director before ANMAT Vigilance contact before ANMAT regarding field actions and product complaints Manages the labeling database for Argentina nationalization labels Prepares and updates “technical datasheets” for registered products in Argentina Organizes and administers a database of quality information required, including but not limited to product complaints, field actions, non-conformances, ship holds, and management control changes Develops and updates as necessary, the procedures for Teleflex Argentina Ensures that regulations required for commercialization are met, such as but not limited to the testing procedures of medical equipment after importation and before commercialization, applicable seals, patient trazability labels, and nationalization labelling among others Maintains the quality system (documents and activities) and constantly improve the process involved Liaison between the warehouse and Teleflex Argentina about ship holds, including restrictions and disposition of products locally Communicates any potential or significant quality issues caused or received by at the warehouse, such as but not limited to water damage, warehouse control failures in temperature, humidity, pest control, or cleaning Manages the GMP certificates, when applicable, related to manufacturing and perform the necessary interfaces Submits to ANMAT the technical documentation required to maintain the product licenses updated and available to import Supports the importation process Regulatory Affairs function through the following activities: Conducts appropriate research to develop strong regulatory strategies for new products and amendments coming from Regulatory Impact Assessments Assumes full responsibility for project submissions, from guidance/strategies/ authoring/obtaining approvals Working with other Quality functions, Operations, Engineering and other internal groups investigate and recommend solutions to address potential regulatory issues Interacts and negotiates with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks Participates in Risk Management assessments Provides feedback regarding impact assessments Reviews and approves all Labeling (product, advertising and promotional) verbiage Assists in regulatory due diligence process Leads departmental SOP development and implementation and maintain regulatory files as required by departmental procedure Ensures product active licenses are accurately reflected in a Market Registration and registered codes uploaded into the Ship Control Table Monitors impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders Complies with Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards Maintains Teleflex systems updated according to regulatory product lifecycle Releases / Blocks product versions based on product license and local regulations Education / Experience Requirements Bachelor degree in Chemistry or Pharmaceutics A minimum of 7 years of professional experience in coordinating logistics, warehousing, customs, and transportation processes (preferably with a medical device manufacturer or large manufacturing-based organization) Complete knowledge of ANMAT, FDA, cGMP, and ISO quality system requirements for a diverse medical device manufacturer ISO 13485 and ISO 9001 audit certified preferred but not required Specialized Skills / Other Requirements SAP ECC Supply Chain Modules proficiency required MS Office Suite required Lean and Six Sigma management methodology experience preferred Teleflex is an equal opportunities employer. #J-18808-Ljbffr