Veterinary Medical SME

FDA Veterinary Medical SME Position Description

 

The successful candidate will serve as a clinical and technical authority to a variety of internal and external stakeholders regarding an array of medical and radiological health products. They will provide scientific, technical, product development, and product validation advice as part of research protocol review, assessment of technical data included in regulatory submissions, as relevant to regulatory review of medical devices. Such submissions include Premarket Notification (510(k)), Premarket Approval Application (PMA), etc.

 

Qualifications

• The candidate must possess a Doctor of Veterinary Medicine (DVM) degree or equivalent, and an unrestricted license to practice veterinary medicine in a state or territory of the United States.
• Additional advanced degrees (MS, PhD) or Board certifications in a related/applicable field are strongly preferred.
• 7 years of experience is required (clinical, academic, and/or industry experience)
• General knowledge and experience with a variety of medical device development technical disciplines
• Exceptionally strong written and verbal communication skills
• Ability to communicate well with others using excellent written and verbal communication skills.
• Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)

Responsibilities

• The contractor shall provide expert consultant service in the area of Veterinary Medicine and use of animal models as related to Human Medical Device Regulatory Review, consistent with (but not limited to) the following consensus standards:
• FDA “Guidance for Industry and Food and Drug Administration Staff” documents and webinars, applicable to animal use and/or medical devices, such as General Considerations for Animal Studies for Medical Devices Draft Guidance for 4 Industry and Food and Drug Administration Staff - DRAFT GUIDANCE (October 14, 2015) LINK and Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff
• Applicable international or other consensus standards relevant to medical device evaluation within biological systems, such as “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” dated September 4, 2020.
• Consensus sources within the discipline of veterinary medicine, which define standards and best practices for use of animals within applicable research settings, such as the National Research Council Guide for the Care and Use of Laboratory Animals, 8th edition, and the Guide for the Care and Use of Agricultural Animals in Research and Teaching
• Provide expert consultation services to OHT review teams in support of medical device reviews, specifically applying expertise in the planning, conduct and review of animal studies used to validate the feasibility, safety and/or efficacy of medical devices. These aspects are directly relevant to the medical device design validation and hazard assessment process.
• Participate in meetings to discuss these device submissions with both internal and external sponsors
• Write reviews and assist with development of other documents as needed
• Assist OHT staff as needed with projects in OPEQ’s OHTs including but not limited to:
• Assist with conducting interviews
• Attending meetings
• Data analysis
• Communications with internal and external stakeholders
• Assist with writing drafts of internal and external communication

 

Job Type:  Full Time Employee

Schedule:  Monday through Friday (No Holidays)

Location:  This position is 100% telework. 

Must be a US Citizen or a Full Green Card holder.