Come join the MicroAire Team! We are seeking a Principal Regulatory Affairs Specialist who can work with New Product Development on implementing regulatory pathway strategies for new markets and/or products. This position will have full responsibility for maintaining domestic regulatory compliance for existing product portfolio. The ideal candidate will be a diligent fact finder, with excellent follow-through and record keeping skills.
A bachelor’s degree in related field, five years of applicable FDA Class II/III medical device regulatory experience, experience in 510(k) submissions and IDE's required. The ideal candidate will have authored 3-5 510(k)’s. Experience working with medical device clinical trials management/oversight, orthopedic devices and interactions with FDA and foreign regulatory bodies preferred. RAC desirable.
MicroAire is a manufacturer and distributor of powered surgical instruments, sterile-packaged disposable orthopaedic accessories, SmartRelease-ECTR, PAL power-assisted liposuction, LipoFilter and Endotine bioabsorbable implants. MicroAire is a team dedicated to enhancing quality of life: For Surgery…For Life
MicroAire is located in beautiful Charlottesville VA. home of University of Virginia and two large hospitals, Charlottesville is consistently ranked as one of the best places to live in America. We offer an excellent benefits package & compensation commensurate with experience. Please email your resume to: email@example.com (EOE)