Regulatory Affairs Specialist

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. 

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