Veterinary Medical SME

<div class="content-intro"><div class="elementor-element elementor-element-8b9cdc3 elementor-widget elementor-widget-text-editor" data-id="8b9cdc3" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <div class="elementor-text-editor elementor-clearfix"> <p><span style="color: #000000;">Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.</span></p> </div> </div> </div></div><p><strong><u>FDA Veterinary Medical SME Position Description </u></strong></p> <p><strong><u> </u></strong></p> <p>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.</p> <p> </p> <p>Qualifications</p> <ul> <li>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.</li> <li>Additional advanced degrees (MS, PhD) or Board certifications in a related/applicable field are strongly preferred.</li> <li>7 years of experience is required (clinical, academic, and/or industry experience)</li> <li>General knowledge and experience with a variety of medical device development technical disciplines</li> <li>Exceptionally strong written and verbal communication skills</li> <li>Ability to communicate well with others using excellent written and verbal communication skills.</li> <li>Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.</li> <li>Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)</li> </ul> <p>Responsibilities</p> <ul> <li>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:</li> <ul> <li>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</li> <ul> <li>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.</li> <li>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</li> </ul> </ul> <li>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.</li> <li>Participate in meetings to discuss these device submissions with both internal and external sponsors</li> <li>Write reviews and assist with development of other documents as needed</li> <li>Assist OHT staff as needed with projects in OPEQ’s OHTs including but not limited to:</li> <ul> <li>Assist with conducting interviews</li> <li>Attending meetings</li> <li>Data analysis</li> <li>Communications with internal and external stakeholders</li> <li>Assist with writing drafts of internal and external communication<strong> </strong></li> </ul> </ul> <p><strong> </strong></p> <p><strong>Job Type:</strong>  Full Time Employee</p> <p><strong>Schedule:</strong>  Monday through Friday (No Holidays)</p> <p><strong>Location:</strong>  This position is 100% telework. </p> <p>Must be a US Citizen or a Full Green Card holder.</p> <p> </p><div class="content-conclusion"><p><span style="color: rgb(0, 0, 0);"><em><span data-olk-copy-source="MessageBody">Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. 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.</span></em></span></p> <p><span style="color: rgb(0, 0, 0);"><em><span class="TextRun SCXP18220292 BCX0" lang="EN-US" data-scheme-color="@000000,1," data-usefontface="false" data-contrast="none"><span class="NormalTextRun SCXP18220292 BCX0">Please be advised that certain client contracts may </span></span><span class="TextRun SCXP18220292 BCX0" lang="EN-US" data-scheme-color="@000000,1," data-usefontface="false" data-contrast="none"><span class="NormalTextRun SCXP18220292 BCX0">outline specific requirements for onsite work. Tunnell </span></span><span class="TextRun SCXP18220292 BCX0" lang="EN-US" data-scheme-color="@000000,1," data-usefontface="false" data-contrast="none"><span class="NormalTextRun SCXP18220292 BCX0">employees and/or contractors are expected to </span></span><span class="TextRun SCXP18220292 BCX0" lang="EN-US" data-scheme-color="@000000,1," data-usefontface="false" data-contrast="none"><span class="NormalTextRun SCXP18220292 BCX0">comply with all client requirements, including any </span></span><span class="TextRun SCXP18220292 BCX0" lang="EN-US" data-scheme-color="@000000,1," data-usefontface="false" data-contrast="none"><span class="NormalTextRun SCXP18220292 BCX0">safety and health protocols.</span></span></em></span></p></div>

Back to blog

Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...