Roberta Hines, senior advisor, has 30 years of senior level experience as a successful regulatory professional in the medical device industry.
Roberta brings a unique blend of expertise in regulatory affairs, quality assurance and clinical research in Class I, II and III devices including a wide variety of medical devices:
- surgical and percutaneous cardiovascular implants;
- implantable orthopedic devices;
- neurovascular implants;
- interventional cardiology and endovascular devices;
- combination drug/device products;
- diagnostic cardiovascular devices;
- peripheral staple and atherectomy devices;
- various ancillary accessories; and,
- medical equipment including software and hardware driven devices.
With her experience in strategic regulatory and clinical research planning, Roberta guides companies in bringing their products from concept through global market introduction in the fastest time possible. Additionally, Roberta is an expert in the design and development of Quality Management Systems and has implemented these systems for many companies.
Office: (888) 33 – 13485 Ext. 4