Rapidly growing Med Device Manufacturer seeking a Regulatory Affairs Manager in Austin, Texas! Relocation assistance is provided for the right applicant! The Regulatory Affairs Manager will have 1 direct report.
The ideal candidate will possess the following:
· Bachelor's degree in science, engineering or related field, with 7-10 years of regulatory experience.
· Experience with FDA Class II or III devices or experience with EU Class IIa/IIb or III devices.
· Strong analytical, technical writing, communication, organizational, time management, and interpersonal relationship skills.
· Awareness of global regulatory affairs, product development and total product lifecycle processes.
· Ability to comprehend principles of engineering, physiology, and medical device use.
· Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects.
· Ability to effectively manage and prioritize numerous projects in a fast-paced environment.
· Expertise in Microsoft Office Suite.
· Experience with US FDA correspondence, TGA and Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices or human tissue.
· Experience leading cross-functional teams with some prior management experience.