Regulatory Affairs Specialist

Position Summary

The Regulatory Affairs Specialist will develop regulatory strategies and submissions as part of the Global RA/QA team that supports Teleflex Medical’s Anesthesia and Emergency Medicine (AEM) Business Unit (BU). Submissions will be regionally based for our medical device products, with a focus on United States (US), European Unition (EU), and Canada regulations. Devices span a wide portfolio and include airway, emergency medicine, pain management, mucosal atomization, and hemostatic products. 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.

Principal Responsibilities

•    Develop regulatory strategies for product development and launch of moderate-complexity projects.
•    Review and assess design and manufacturing changes for potential impact on current regulatory filings.
•    Ensure compliance with design controls and review design documentation to confirm that it follows the regulatory requirements.
•    Interpret existing regulations and guidance documents within regulatory department and on project teams.
•    Provide regulatory expertise and oversight to design teams.
•    Identify risk factors and contingency planning for assigned projects as related to regulatory decision making.
•    Review product development to ensure collection of appropriate data for regulatory submissions and regulatory compliance.
•    Interact and negotiate 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 agencies 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 US. 
•    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 labelling (product, advertising and promotional) verbiage.
•    Understand and communicate regulatory processes, guidelines and guidance documents and what they mean to the organization.
•    Apply understanding of the quality systems to job activities and projects.
•    Participate in training RA team members and others on compliance matters.
•    Bring Regulatory Affairs questions/issues to the attention of RA management.
•    Prepares update reports for RA management.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
•    Perform other duties as assigned or necessitated by business conditions or changes.

Education / Experience Requirements

•    A bachelor’s degree in a science or engineering field is preferred.  
•    Minimum of 2 to 4 years of experience working in medical device regulatory affairs (or equivalent regulated industry).
•    Experience in the skillful preparation of regulatory submission dossiers for class I or II medical devices is highly preferred. 

Specialized Skills / Other Requirements

•    Advanced English communication skills (verbal and technical writing).  
•    Strong attention to detail.  
•    Strong analytical and critical thinking skills.  
•    Ability to organize, prioritize, manage multiple projects and meet deadlines.  
•    Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality.  
•    Knowledge of electronic document management systems. 
•    Ability to apply Business and Regulatory Affairs ethical standards.  
•    Proficiency in MS Word, Excel, Power Point, and Outlook.