Regulatory Affairs Specialist

　　Date: Jan 23, 2024

　　Location: Wyomissing, PA, US

　　Company: Teleflex

　　Expected Travel : None

　　Requisition ID :9538

　　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. For more information, please visit teleflex.com.

　　Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

　　Position Summary

　　This is a mid-level regulatory affairs position that requires the ability to integrate regulatory knowledge throughout the product lifecycle with effective project coordination. The position supports the Regulatory Affairs function and the organization by communicating regulatory strategies and preparing the regulatory documentation necessary to support market authorizations. The position supports the maintenance of regulatory information systems. Effective communication and proficient technical writing skills are essential.

　　Principal Responsibilities

　　• Participate in multidisciplinary teams and communicate regulatory requirements effectively

　　• Provide regulatory input to product lifecycle planning

　　• Evaluate regulatory impact of proposed design and manufacturing changes to commercially distributed medical devices

　　• Conduct appopriate research to develop strong regulatory strategies for new products

　　• Determine issues which may create regulatory obstacles and investigate solutions

　　• Prepare and submit applicable regulatory documentation, as required (with focus on the US, EU and Canadian markets) and/or compile necessary documentation as requested by in-country Regulatory Affairs personnel

　　• Monitor progess of submission reviews and interact with regulatory agencies, as appropriate

　　• Participate in risk managemen assessments

　　• Review and approve product labeling, advertising and promotional information for regulatory compliance

　　• Assist with SOP development and implementation

　　• Maintain regulatory information systems

　　• Support device import/export and distribution control activities

　　• Support regulatory compliance inititiatives

　　• Monitor impact of changing/evolving global regulations on submissions, practices and procedures and communicate to appropriate personnel

　　• Other duties as assigned by the Regulatory Affairs management team

　　• Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, ules, procedures and housekeeping standards

　　Education / Experience Requirements

　　• Associate or Bachelor’s degreee preferably in the science or engineering disciplines

　　• 2-5 years in a medical device organization, preferably in regulatory affairs

　　• Previous 510(k) experience preferred

　　• RAC certification preferred, but not required

　　• Ability to apply business and Regulatory Affairs ethical standards; analytical and critical thinking skills

　　• Strong communication skills (verbal and technical writing)

　　• Ability to manage multiple projects and meet deadlines

　　• Proficient in MicroSoft Office Suite

　　Specialized Skills / Other Requirements

　　Must be a well-organized self-starter that takes the initiative for independent work with attention to detail and has an ability to follow written and verbal instructions.

　　Manage assigned projects and related activities, propose market authorization strategies, effectively participate on cross-functional teams and identify and solve mid-level problems.

　　Must possess a basic understanding of product risk/benefit concepts, working knowledge of US and International regulations applicable to market authorization for Vascular products, good verbal communication, technical writing, intra- and interdepartmental communication and collaboration skills.

　　#LI-DR1

　　Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.

　　Teleflex is an equal opportunities employer

　　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 U.S. and/or other countries.