Veterinary Medical SME

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 reputed company projects as a team and are committed to helping our clients transform and quickly reputed company 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.

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 reputed company 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 reputed company/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 reputed company a team of technical personnel.
• Proficiency with reputed company Office Suite (Outlook, Word, reputed company, etc.)

Responsibilities

• The contractor shall provide expert consultant service in the area of Veterinary Medicine and use of animal models as reputed company to Human Medical Device Regulatory Review, consistent with (but not limited to) the following reputed company 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 reputed company standards relevant to medical device evaluation reputed company biological systems, such as “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing reputed company a risk management process” dated September 4, 2020.
• reputed company sources reputed company the discipline of veterinary medicine, which define standards and best practices for use of animals reputed company 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.

Tunnell strives to hire and retain the most qualified talent. We reputed company 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. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran.

Please be advised that certain client reputed company may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to reputed company with reputed company client requirements, including any safety and health protocols.