Regulatory Affairs Specialist

Position Summary

The Regulatory Affairs Specialist will develop strategies and submissions for Teleflex Medical. Submissions will be globally based for our medical device products, including devices in Anesthesia, Emergency Medicine, Interventional Cardiology/Radiology, Surgical, Urology, and vascular access products. Submissions will be moderate to complex 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 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.
• Interpret existing regulations and guidance documents within the regulatory department and on project teams.
• Provides regulatory expertise and oversight to design teams.
• Identify risk factors and contingency planning for assigned projects.
• Review product development to ensure appropriate data collection for regulatory submissions and compliance.
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval and during audits to mitigate any potential risks.
• Interfaces 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 to authoring/obtaining approvals, including revision of 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required to support product registration/licensure.
• 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.
• Interact and support Strategic Regulatory Affairs groups, as required, in operations & systems, intelligence & stewardship, business critical projects, strategic programs and mergers & acquisitions.
• 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.
• Brings Regulatory Affairs questions/issues to the attention of RA management.
• Adhere to and ensure compliance with Teleflex’s Code of Conduct, as well as all company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

• A bachelor’s degree in a science or engineering field is preferred. 
• More thsn 5 years of regulatory affairs experience in a regulated environment is required.
• Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I, II, or III medical device experience, is highly preferred.

Specialized Skills / Other Requirements

• Strong 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, PowerPoint, and Outlook