Mark Martino

Background

About Mark Martino

Quality/Regulatory Specialist with more than 17 years Medical Device Industry experience. I am an expert at identifying flaws and weaknesses in systems and game planning on how to effectively minimize their impact. I have implemented a process of active monitoring of incoming events which has helped to identify improper reporting decisions early on in the complaint process. I have broad industry experience having worked at some of the largest healthcare firms in the medical device sector and have had a number of opportunities to be a part of efforts to re-vitalize and restructure the post market groups at these firms. I strive when placed in challenging, fast paced environments and require little monitoring to follow through with project deadlines.Highly skilled at both writing and reviewing Medical Device Reports (MDR) and Medical Device Vigilance Reports (MDVR). Experienced working as a member of cross-functional teams; including members from user facilities, complaint investigation sites, quality, safety, sustaining engineering and regulatory affairs.I am trained and knowledgeable on the FDA’s Quality System Regulation (QSR) 21 Code of Federal Regulations (CFR) Part 820, as well as the international standard ISO 13485.Specialties: Results-oriented, detailed professional who is organized, disciplined, and analytical. Excellent critical thinking and problem-solving skills demonstrated by identification of problem areas, exploration of resolutions, and implementation of solutions. Resourceful, adaptable, and a team player.