About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference.

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 Regulatory Operations Manager will be responsible for leading regulatory staff and product registrations, including preparing regulatory strategies, managing submissions and interactions with third parties and/or various regulatory agencies. The incumbent is also responsible for staying abreast of evolving regulatory requirements in the region such as maintain current worldwide regulatory registrations and device listings, maintain release of product distribution as part of product commercialization worldwide, ensure regulatory requirements are met per quality management systems, assess data from RIA and support commercial RA to ensure global market authorization needs and manage projects independently based on corporate objectives.

Principal Responsibilities

• Lead and manage day to day activities and regulatory staff.
• Determine and support regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products Globally.
• Support and advise multidisciplinary teams and communicate regulatory requirements effectively to meet project needs.
• Monitor global regulations/guidelines and the impact of changing/evolving regulations on submissions, practices and procedures and communicate to appropriate stakeholders.
• Interact with BU RA to facilitate ROW registrations and tracking as needed
• Conduct and oversee appropriate research to develop strong regulatory strategies for new and modified products, as well as strategic business projects.
• Oversee and direct the development of priorities, timelines, receipt of technical information from appropriate sources.
• Support tracking of Regulatory Operations Metrics
• Review and evaluate issues which may create regulatory or business obstacles and investigate solutions.
• Support and participate in regulatory inspections, as needed.
• Deliver regular updates of all relevant regulatory activities and issues.
• Apply understanding of the quality systems to job activities and projects.
• Train, develop, and mentor staff as appropriate.
• Support tracking of Metrics
• Provide input to Supply and Demand Planners as needed.
• Ensure business risks have appropriate mitigation and contingency plans are in place.
• Support Regulatory procedureal consolidation/updates while maintaining QS compliance.
• Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards

Note: 0% of this job involves direct R&D activities

Education / Experience Requirements

• English proficiency is a Must - written and verbal skills
• Bachelor Degree in engineering, medical, or science field.
• Experience of 7+ years in Regulatory areas for Medical Devices.
• Experience of 4+ years in a Regulatory Affairs/Compliance leadership role with at least 4 direct reports.

Salary / Benefits

• Hybrid Position (Home Office + On Site) Office near Metrobus Napoles / Monday - Friday 8am to 5pm
• $70,000 to $75,000 MXN Monthly
• Permanent Contract
• Superior Law Benefits
• 30 days Year End Bonus
• Medical Insurance
• 13% Saving Fund
• Grocery Vouchers

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the US and/or other countries.

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