Regulatory Affairs Specialist

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 manufac...