Long standing company, known for long tenured employees; great growth potential.

• The Regulatory Affairs Associate supports the Regulatory Affairs group and works under the direction of the Dept. Head to ensure Regulatory projects are completed in a thorough, accurate, and timely manner 
• This individual assists in the creation, update, storage, organization, and maintenance of all regulatory documentation including, Project Applications, Product Cards, Device Master Records, Letters to File, and 510(k) submissions
• Assists and supports all aspects of the complaint, MDR and recall processes including processing, reporting, trending, resolution, and documentation of all reportable and non-reportable incidents
• Assists in the compilation of information to be submitted to regulatory authorities and help prepare regulatory submissions and / or responses 
• Recommends and investigates solutions to quality and regulatory issues 
• Works within the team to develop procedures and associated forms for assigned areas and assures their implementation
• Complies with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820 & ISO 13485

• Aware of and comply with the Quality Manual and applicable laws and regulations as they apply to this job type/position.
• Complete all planned Quality & Compliance training within the defined deadlines
• Other duties as assigned

• B.S. Degree preferred; or 3-5 years appropriate experience necessary.
• Working knowledge of 21 CFR 7, 803, 806, 810, and 820
• Familiarity with processing and managing complaints, MDRs and / or filing 510ks and responding to FDA inquiries
• Must have knowledge of Good Manufacturing Practices Requirements and experience in a regulated medical manufacturing environment
• Excellent organizational skills and able to work independently
• Excellent communication skills
• Intermediate - Advanced PC experience with spreadsheets, letter writing and presentation applications.