Regulatory Affairs Specialist

Teleflex; North Carolina; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player in medical technologies is seeking a Regulatory Affairs Specialist to enhance healthcare solutions. This role involves developing regulatory strategies, ensuring compliance with design controls, and interacting with regulatory authorities for product submissions. The ideal candidate will possess strong analytical and communication skills, a solid understanding of regulatory requirements, and the ability to manage multiple projects independently. Join a dynamic team dedicated to improving patient outcomes through innovative medical devices and solutions.

Qualifications

• 2-3 years of regulatory affairs experience in a regulated environment is required.
• Basic understanding of medical devices with electrical capabilities is a plus.

Responsibilities

• Develop regulatory strategies for new products from development to launch.
• Review and assess change control activities for potential impact on regulatory filings.

Skills

Analytical Skills

Communication Skills

Organizational Skills

Time Management

Problem Solving

Education

Bachelor’s degree in a science or engineering field

Tools

MS Word

Excel

Power Point

Outlook

Job description

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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 Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning and regulatory agency interaction for the Surgical portfolio. Submissions will be at moderate to complex level, and relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The incumbent is also responsible for staying abreast of evolving global regulatory requirements.

• Develop regulatory strategies for new products from development to launch for moderate-complexity projects and assure collection of appropriate data for regulatory submissions and regulatory compliance.
• Review and assess of change control activities for potential impact on current regulatory filings.
• Ensures compliance with design controls and reviews design documentation to ensure that it follows the regulatory requirements and provide regulatory expertise and oversight to design teams.
• Interpret existing regulations and guidance documents within regulatory department and on project teams. Understand and communicate regulatory requirements and what they mean to the organization, and management.
• Identify risk factors and contingency planning for assigned projects.
• Interact with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.
• Interface as needed with FDA, Notified Bodies or other national health agency regarding new products and significant changes to products.
• Assume full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for registration/licensure of products outside the U.S.
• Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.
• Review and approve all Labeling (product, advertising and promotional) verbiage and evaluate for any regulatory impact.
• Apply understanding of the quality systems to job activities and projects.
• Participate in training RA team members and others on compliance matters.
• Brings Regulatory Affairs questions/issues to the attention of RA management.
• Comply with Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

• English proficiency is a must (B2 level and above)
• Bachelor’s degree in a science or engineering field is preferred.
• 2-3 years of regulatory affairs experience in a regulated environment is required.
• Basic understanding of, or experience with, medical devices with electrical capabilities a plus.
• Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I or II medical devices is highly preferred.

Specialized Skills / Other Requirements

• Strong analytical and critical thinking skills
• Strong communication skills (both verbal and technical writing)
• Strong organizational and time management stills with high level of personal and professional integrity and trustworthiness
• Strong work ethic and the ability to work independently, manage multiple projects with minimal direction, and meet deadlines.
• Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality
• Knowledge of electronic document management systems
• Basic understanding of, and ability to comply with, business and Regulatory Affairs ethical standards.
• Proficient in MS Word, Excel, Power Point, and Outlook required.

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.