Regulatory Affairs Specialist

Position Summary

This is a mid-level Regulatory Affairs position responsible for integrating regulatory knowledge throughout the product lifecycle and coordinating projects effectively. The role supports the Regulatory Affairs team by communicating regulatory strategies and preparing essential documentation for market authorizations. Additionally, the position involves maintaining regulatory information systems. Strong communication and technical writing skills are essential to succeed in this role.

Principal Responsibilities

• Participate in multidisciplinary teams and communicate regulatory requirements effectively
• Provide regulatory input to product lifecycle planning
• Obtain and evaluate the regulatory impact of proposed design and manufacturing changes to commercially distributed medical devices
• Conduct appropriate research to develop strong regulatory strategies for new products
• Determine issues that 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 International Regulatory Affairs personnel
• Monitor progress of submission reviews and interact with regulatory agencies, as appropriate
• Participate in risk management 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 initiatives
• Monitor the impact of changing and 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, rules, procedures, and housekeeping standards

Education / Experience Requirements

• Associate or Bachelor's degree, preferably in the science or engineering disciplines
• Must have 2-5 years in a medical device organization, preferably in regulatory affairs
• Previous US, Canadian, and EU submissions experience preferred
• RAC certification preferred
• Ability to apply business and Regulatory Affairs ethical standards; analytical and critical thinking skills
• Proficient in Microsoft Office Suite

Specialized Skills / Other Requirements

• Must be a well-organized self-starter who takes the initiative for independent work with attention to detail and has the 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