Regulatory Affairs Manager

  • Location: Austin
  • Type: Direct Hire
  • Job #36962

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.

Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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