Regulatory Affairs Specialist - Medical Device

Job Overview

Regulatory Affairs Specialist

Dubuque, IA – On Site

Up to $70k / year + benefits

Seeking a Regulatory Affairs Specialist who will partner closely with the Quality Manager and Engineering teams. The right fit candidate will be responsible for maintaining regulatory compliance as new or revisions of standards and product designs are released, the technical expert to resolve potential regulatory issues, deficiencies, and questions from regulatory agencies. Previous experience in the medical device industry is preferred. This is a direct hire opportunity, and the right fit candidate will go directly onto the hiring company’s payroll.

What we’d like you to bring to the opportunity:

• Bachelor of Science degree required in Healthcare, Biomedical Science, Biology, Chemistry, or related field

• 1 - 3 years of regulatory affairs, quality, or medical device experience (preferred),

• Knowledge of regulatory compliance, sterilization techniques, cleanroom standards.
• Ability to manage databases and reports using necessary programs and the ability to analyze and present data required.
• Solid communication skills and computer proficiencies necessary, including Microsoft Word, Excel, Access, and Outlook. 

Interested in learning more? Great! I would welcome the opportunity to discuss the role in greater detail with you as well. Please share a copy of your professional resume directly: Amanda@careerpros.com