Robert A. Herrmann

Director of Neurointerventional Regulatory Affairs @ MCRA, an IQVIA business

About

In my current position, I am leveraging 20+ years of experience in the medical device field to advance care for patients and assist companies to bring their devices to market. I am detail oriented, have great innovation skills, and a breath of knowledge covering medical devices, biomaterials, physiology, vascular biology, interventional cardiology and wound closure. I have 6 years FDA experience in the neurointerventional device area covering, PMAs, 510(k)s, IDEs, combination products and post-market issues. Strong background in medical device product development and the quality systems used during the product life cycle. I am an encouraging, successful and adventurous collaborator, creating positive team results and lasting relationships with team members, collaborators and CRO’s. Strong communication skills. Proficient in writing and presentation skills for both scientific, business and lay audiences. Prolific innovator with numerous issued patents and published applications. Specialties: Medical Device Regulatory Affairs, Project management, Team Management, Medical Devices, Product innovation, Preclinical Research, Budgeting, Vascular Biology, Wound Healing

Country

United States

City

Washington

Industry

Medical Device

Skill

Program Management, Budget Management, Engineering Management, Medical Devices, Project Management, Product Innovation, Team Management, FDA, Biomaterials, Clinical Development, Combination Products, Design Control, ISO 13485, R&D, Validation, CAPA, Commercialization, Quality System, ISO 14971, Biocompatibility

Experience

Director of Neurointerventional Regulatory Affairs

MCRA, an IQVIA business

2021-8 - Present · 5 yrs 2 mos

Washington, DC, United States

Team Lead Neurointerventional Devices

FDA CDRH

2016-6 - 2021-8 · 5 yrs 3 mos

Silver Spring, Maryland

Lead Reviewer Neurointerventional Devices

FDA CDRH

2015-2 - 2016-6 · 1 yr 5 mos

Silver Spring, Maryland

Vice President Engineering

eVasc Medical Systems

2008-10 - 2015-1 · 6 yrs 4 mos

Engineering Manager

Corza Wound Closure

2006-11 - 2008-8 · 1 yr 10 mos

- Project Manager for the development of two 510K submissions for the Quill barbed suture product. - Led team in the development of improved manufacturing machines,novel product test methods and improved product quality. - Served as chairman of Angiotech’s Animal Care Committee. - Reviewed and approved animal use protocols, developed and modified animal care SOPs. - Inventor on numerous (>10) patent applications.

Principal Scientist, Sr. Research Scientist, Research Scientist

Boston Scientific

2000-1 - 2006-11 · 6 yrs 11 mos

- Team Leader for technology evaluation in the area of drug eluting stents. - Led internal efforts to develop novel drug eluting stent coating in collaboration with small pharmaceutical company and academic scientists. - Mentor and supervise biologist and pharmaceutical scientist. - Led external team in pre-clinical research on drug eluting stent mechanism of action, resulting in three publications. - Initiated corporate program for development of new Pre-Clinical methods and models for drug eluting stent development. - Supported due diligence efforts on biomaterials and pharmaceutical/biotech technologies. - Inventor on six issued patents and numerous patent applications. - Successfully initiated in vitro cell culture assays both internally and externally in support of technology development programs. - Led bi-annual company-wide forum on drug-device combination technology evaluation within Boston Scientific.

Post-Doctoral Researcher

The University of North Carolina at Chapel Hill

1998-9 - 1999-12 · 1 yr 4 mos

- Researched the role of von Willebrand factor in stented atherosclerotic vessels using in situ hybridization and immunohistological techniques. - Assisted in pre-clinical experiments using a porcine infarct model. - Developed antisense RNA marker for von Willebrand factor using molecular biology techniques. - Assisted in pre-clinical experiments using proteosome inhibition of NF-KB to reduce tissue damage in a myocardial infarct model.

Post-Doc / Consultant

Department of Cardiology, Klinikum rechts der Isar, Munich, Germany

1996-9 - 1998-9 · 2 yrs 1 mo

- Establish laboratory for histological and immunohistological evaluation of stented coronary arteries. - Lead research project to develop an anti-restenosis radioactive coronary stent. - Set up laboratory and developed protocols for histological and immunohistological evaluation of stented coronary arteries. - Completed evaluation of radioactive stents in a porcine model. Assisted in manufacture, testing and evaluation of a drug-eluting, polymer coated coronary stent.

Project Engineer

Canon Virginia

1988 - 1990 · 2 yrs

- Led engineering team in start-up of new toner production line. - Brought several domestic raw materials on-line, ensuring product quality. - Provided technical support for toner manufacturing and quality assurance.