[Hiring] Veterinary Medical Subject Matter Expert @Tunnell Government Services

Role 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

• Doctor of Veterinary Medicine (DVM) degree or equivalent
• 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 (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
• 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

• Provide expert consultant service in the area of Veterinary Medicine and use of animal models as related to Human Medical Device Regulatory Review
• Consult on FDA “Guidance for Industry and Food and Drug Administration Staff” documents and webinars
• Apply applicable international or other consensus standards relevant to medical device evaluation within biological systems
• Consult on consensus sources within the discipline of veterinary medicine
• Provide expert consultation services to OHT review teams in support of medical device reviews
• Participate in meetings to discuss device submissions with both internal and external sponsors
• Write reviews and assist with the development of other documents as needed
• Assist OHT staff with projects in OPEQ’s OHTs including but not limited to:
• Conducting interviews
• Attending meetings
• Data analysis
• Communications with internal and external stakeholders
• Writing drafts of internal and external communication

Job Type

• Full Time Employee

Schedule

• Monday through Friday (No Holidays)

Location

• This position is 100% telework

Additional Information

• Must be a US Citizen or a Full Green Card holder
• Tunnell strives to hire and retain the most qualified talent
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran
• Certain client contracts may outline specific requirements for onsite work
• Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols