Sr. Regulatory Affairs Specialist

Teleflex; Ciudad de México; Presencial; MXN 920,000 - 1,290,000; Jornada completa

Descripción de la vacante

A global medical technology provider seeks a Senior Regulatory Affairs Specialist in Mexico City. This role focuses on regulatory activities, ensuring compliance for medical devices in line with US, EU, and Canada regulations. Candidates require a Bachelor's in Science or Engineering and 5+ years in the industry, specifically with Class II devices. Strong technical writing and problem-solving skills are essential, along with fluent English proficiency.

Formación

• 5+ years of experience in the medical device industry.
• Experience with Class II or higher registrations.
• Fluent in English, both written and oral.
• Strong understanding of US, EU, and Canada medical device regulations.

Responsabilidades

• Develop and execute regulatory strategies for new products.
• Conduct regulatory research and assessments.
• Collaborate with cross-functional teams to manage regulatory activities.
• Interact with regulatory authorities for product lifecycle management.

Conocimientos

Technical writing

Regulatory compliance

Problem solving

Attention to detail

Communication skills

Educación

Bachelor Degree in Science or Engineering

Herramientas

MS Office

Descripción del empleo

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 Senior Regulatory Affairs Specialist will focus on the regulatory activities and deliverables to strategically assess and support related regulatory tasks including simple to complex submission writing. This role will be responsible for strategy and facilitating compliant, streamlined execution of regulatory affairs activities related to implementation of multi‑business unit operations initiatives. This role is responsible for effectively partnering with PM RA, Regional RA, Reg Ops and cross‑functional teams and a varied group of stakeholders to aide in regulatory strategy and execution for operations programs.

• Develop and execute comprehensive regulatory strategies for new and modified products, including PMA, IDE, 510(k), MDR Technical Documentation, and Health Canada submissions, ensuring compliance with US, EU, and Canadian regulations.
• Conduct regulatory research and assessments using applicable standards, guidance documents, and prior approvals to support sound regulatory decision‑making across Business Units.
• Partner with Regional and Business Unit Regulatory Affairs to develop and implement global registration strategies, ensuring alignment on deliverables and timelines.
• Collaborate with cross‑functional teams—including Quality, Engineering, Operations, Sterilization, Biocompatibility, and Manufacturing—to manage regulatory activities, maintain compliance, and meet project milestones.
• Interact and negotiate with regulatory authorities and Notified Bodies to support product lifecycle management, including FDA pre‑submission meetings, PMA/510(k) filings, Health Canada submissions, and EU MDR Technical Documentation.
• Review and assess change control activities, risk management documentation, and design control deliverables to ensure regulatory compliance throughout the product lifecycle.
• Provide regulatory input for post‑market surveillance activities, labeling, and promotional material review to ensure claims are accurate and compliant.
• Support and prepare for regulatory agency and Notified Body audits, maintaining accurate and inspection‑ready documentation.
• Identify and communicate potential regulatory risks, propose mitigation strategies, and recommend process improvements to enhance compliance and operational efficiency.
• Monitor evolving global regulatory requirements and communicate key changes and impacts to internal stakeholders.
• Contribute to continuous improvement initiatives within Regulatory Operations, including updates to departmental procedures and documentation practices.

Education / Experience Requirements

• Bachelor Degree in Science or Engineering disciplines.
• Minimum 5+ years of experience working within medical device industry; 3+ years with Class II or higher registrations.
• Knowledge and understanding of US, EU and Canada medical device regulations, standards, and guidance documents.
• Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required
• Excellent technical writing experience within a medical device environment – essential
• Attention to detail and accuracy – essential
• Fluent in English, both written and oral – essential
• Ability to work well under deadlines and pressure
• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS‑Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
• Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management

Specialized Skills / Other Requirements

• Highly organized with strong attention to detail and ability to prioritize multiple tasks.
• Self‑starter who takes initiative and follows through on written and verbal instructions.
• Excellent written and verbal communication skills with strong cross‑functional collaboration.
• Skilled in proofreading technical documentation for accuracy and consistency.
• Demonstrated problem‑solving ability; adaptable to shifting priorities and changing project needs.
• Proficient in Microsoft Office (Excel, Word, PowerPoint) and statistical or analytical software.
• Knowledge of Corrective Action, Manufacturing, and Design Control concepts preferred.
• Positive, proactive, and effective in working across teams and with leadership

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.