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 arrowtm, barrigeltm, deknateltm, quikclottm, lmatm, pillingtm, rüschtm, urolifttm and wecktm – 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 summarythe sr.regulatory affairs specialist will lead the development of regulatory strategies, assessments, and submissions for complex projects across the u.s., european union, and canada.this role is responsible for reviewing and advising on regulatory documentation, investigations, product development plans, and interactions with regulatory authorities.additionally, this position will support the mentoring and professional development of regulatory specialists as part of their leadership responsibilities.conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments for the u.s., european union and canada for new and modified products.assume full responsibility for project submissions for 510(k) premarket notifications, eu mdr technical documentation, and canadian license submission/amendments.communicate with commercial ra to ensure timely notification of changes as appropriate.partner with commercial ra to support registration of product in foreign markets.work with quality, operations, engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts.interact and negotiate with regulatory authorities during the development (i.e. Q-sub, change notifications, etc.) and submission review.support regulatory agency and/or notified body audits by as needed.participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.participate in development and approval of risk activities as well as other deliverables as related to projects.provide regulatory review for reporting activities required by eu mdr (i.e. post-market surveillance, reporting, etc.).review and approve all labeling (product, advertising and promotional) and ensure claims are substantiated.assist in regulatory due diligence process as needed.proactively drive ra project deliverables by collaborating cross-functionally and engaging with cross-business unit team members as needed.monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.brings regulatory affairs questions/issues to the attention of ra management.comply with teleflex's code of ethics, all company policies, rules, and procedures.education / experience requirementsadvanced english level.bachelor's degree in a science or engineering field, or equivalent work experience.5+ years of medical device regulatory affairs experience, domestic and international.3+ years of experience with class i, ii or iii medical devices.proven history of successful domestic and/or international submissions.specialized skills / other requirementsstrong analytical and critical thinking skills.strong verbal and technical writing communication skills.ability to manage and prioritize multiple projects to meet deadlines that align with the bu's objectives.proven track record of working as a team player to overcome obstacles and complete tasks through collaboration.proficiency in ms office software programsrac certification is a plus.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, arrowtm, barrigeltm, deknateltm, quikclottm, lmatm, pillingtm, rüschtm, urolifttm and wecktm are trademarks or registered trademarks of teleflex incorporated or its affiliates, in the u.s. and/or other countries.#j-*-ljbffr