Samuel Shimp Email & Phone Number

New Brunswick, New Jersey, Us

Leading a Regulatory Affairs team responsible for regulatory filings and documentation of- Life-Cycle Management changes (Cost Improvement, Supplier Changes, Etc.)- IFU and Direct to Patient Labeling content compliant to FDA and EU MDR regulations- New Product DevelopmentMy team is directly responsible for pre-market regulatory filings for the US and EU. (PMA, HDE, IDE, 510(k), EU MDR, and UKCA.We support regulatory teams around the world to meet global regulatory requirements.We also support external audits for MDSAP, ISO 13485, MDR, and UKCA.

Irvine, California, Us

Regulatory AffairsMy team is directly responsible for pre-market regulatory filings for the US and EU. We also support regulatory teams around the world to meet global regulatory requirements.

Irvine, California, Us

Regulatory Affairs

Regulatory Affairs

Berlin, De

* Regulatory Project Management for Vascular Intervention Products* Project leader for Original PMA, IDE, Traditional/Special 510(k), Pre-submission and HUD/HDE submissions* Organizing and motivating team members from R&D, regulatory, and quality systems to complete critical tasks and achieve milestones on time* Provide regulatory considerations for all stages of product development* Develop regulatory strategies to get products to the US market quickly while minimizing costs* Facilitated interaction with FDA through face-to-face meetings and phone calls* Overhaul internal processes in order to improve speed & consistency in regulatory process, strategy, and decision making* Interact / support engineering, R&D, QA, manufacturing, marketing* Report regularly and directly to to executive, business development, and product managersExperience Gained:Project and interpersonal leadershipBusiness development and managementDevelopment of regulatory processesWorking within a Medical Device Quality System

Silver Spring, Md, Us

Medical Device Reviewer - Neurodiagnostic and Neurosurgical Branch* Reviewed neurosurgical devices with an emphasis on Neurovascular interventional devices and Neurosurgical shunts.* Primary reviewer of mechanical neurothrombectomy devices (clot retrievers), neurovascular stents, and neurovascular catheters.* Experienced with Submission Types: PMA, IDE, 510(k), Pre-submission, HDE and De Novo* Gained strong understanding of medical device regulations, technical requirements for medical devices, and practical workings of the FDA.* Learned how to successfully negotiate with FDA to successfully obtain device approvals / clearances* Developed strong interpersonal skills to manage people with differing scientific opinions* Managed delivery of technical teams to deliver medical device reviews on time for timely FDA approvals* Initiated development of guidance document for neurovascular medical devicesExperience Gained:US Medical device regulationsNegotiationTeam management

Blacksburg, Va, Us

* Applied mechanical engineering analysis and biological laboratory techniques to model, characterize and experimentally test inflammation in biological systems.* Performed: microbiology experiments* Conducted drug proof of concept studies in animal models* Developed computational modeling / computer simulations to evaluate drug mechanisms of action* Planned experiments within constraints of budget and project scope* Co-wrote grant proposals to NIH and NSF* Provided technical support for diverse projects across department and university* Manage and trained volunteer research assistantsExperience Gained:Extensive technical skillsProject managementSmall team leadership

Blacksburg, Va, Us

Project manager for a 12 person team working to develop a safe, clean drinking water supply for a rural village in Guatemala* Improved team communication & productivity through carefully planned meetings* Used Spanish language skills to communicate with stake holders, int’l engineering firms, & local service providers* Responsibilities: - assigned tasks to team members - reviewed design proposals and project plans - managed project budget that included expenditures for international travel, materials, contracting of equipment, and supply logistics - interacted with project donors to raise funds through meetings, presentations, and phone calls - wrote guidelines for on-site testing & community interaction Experience Gained:Project managementTeam leadershipBudgeting and fundraising

Blacksburg, Va, Us

Engineering control and signal processing algorithms for mechanical designs, acoustics, and speech processing* Developed novel control algorithms* Developed signal processing algorithms for speech processing* Tested electro-mechanical control algorithms on automotive vehicle suspensions

Hampton, Virginia, Us

Mechanical design and control algorithm development for four-wheeled mobile robot (rover)

Ph.D., Biomedical Engineering

M.S., Mechanical Engineering

B.S., Mechanical Engineering

Associate Of Arts - Aa