Tamara Brey, B. Eng., Jd Email & Phone Number

Biomedical Engineer and Law Graduate focused on Medical Device Regulatory Affairs and Compliance Management. • 4 years of experience in Corporate Regulatory Affairs. 12 years of combined FDA related experience: FDA auditor, Clinical Research Associate, FDA Attorney • Juris Doctors, License in IL. U.S. Patent and Trademark Office Registration.• Ability to work individually, within a multi‐disciplinary team, as well as with external partners and vendors.• Strong written and presentation skills.• Experienced in developing regulatory submissions to the Food & Drug Administration, IDE, IDE Progress Reports, 510(k), Hold Letter Response as well as post‐submission application support.• Strong research, analytical and problem solving skills• Experienced with EU MDD Technical File management.• Worked at FDA ORA Chicago District Office • Reasonable understanding of the manufacturing issues that can affect implantable medical devices. • Background working in Clinical Trial design, protocol review, informed consent review, and execution.• Experienced in Adverstising and Promotion rules, Design Controls and in MDSAP support.• Experienced in daily regulatory challenges, e.g. GUDID, Change Control, Global Trade

Listed skills include Legal Research, Legal Writing, Patent Prosecution, Patentability, and 42 others.