Sr. QARA Specialist

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About Teleflex Incorporated

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. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

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. For more information, please visit teleflex.com.

Latin America - 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. The Latin America Region sells a broad spectrum of medical devices and related products in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. As Teleflex grows and expands its portfolio, we will continue to grow our presence in Latin America. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

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. Establishes metrics, analyzes trends and reports on employee training compliance data.

On the Regulatory side, the Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. Where applicable, this position will assist in mentoring and development of staff members as part of the role.

The Sr. RAQA Specialist supports global quality and regulatory projects impacting local operations.

Principal Responsabilities

Quality Assurance function through the following activities, but not limited to:

• 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 store 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 treatement 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 standars 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, but not limited to:

• 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 assesments
• Reviews and approve 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 accuratedly 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

• BS or BA degree in Engineering, Science, or a related field; preferred pharmaceutical
• 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 with ANMAT, FDA, cGMP, and ISO quality system requirements for a diverse medical device manufacturer.
• ISO 13485 ISO 9001 audit certified preferred but not required.

Specialized Skills / Other Requirements

• SAP ECC Supply Chain Modules proficiency (Required)
• MS Office Suite
• Advanced Excel proficiency in Pivot tables, advanced functions, filters (Required), and Macros (Preferred)
• Lean and Six Sigma management methodology experience (Preferred)

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

• Job function Administrative, Quality Assurance, and Manufacturing
• Industries Medical Equipment Manufacturing, Public Health, and Manufacturing

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