Tunnell Government Services, Inc.
MEDICAL OFFICER (OTOLARYNGOLOGIST [ENT])
Tunnell Government Services, Inc., Bethesda, Maryland, us, 20811
MEDICAL OFFICER (OTOLARYNGOLOGIST [ENT])
2 days ago Be among the first 25 applicants 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. FDA CDRH – Medical Officer (Otolaryngologist [ENT]) SME Position Description. The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, HDE and De Novo marketing applications, Pre-submissions, Investigational Device Exemptions, Recalls); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and otolaryngology, as relevant to medical devices. Responsibilities
Provide expert consulting services to assist the CDRH with regulatory responsibilities related to medical devices. Support medical device reviews and regulatory submissions (e.g., EUA, 510(k), PMA, HDE, De Novo). Participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders. Develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports. Perform other administrative office tasks related to CDRH projects. Requirements And Qualifications
The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. Current, active, full, and unrestricted medical license or registration to practice medicine in a U.S. state, District of Columbia, Puerto Rico, or a U.S. territory. At least fifteen (15) years of relevant clinical experience. Certification from a U.S. relevant specialty board organization (e.g., American Board of Otolaryngology – Head and Neck Surgery). Thorough understanding of current clinical practices in otolaryngology, including diagnosis and treatment, and current/emerging trends in practice. Knowledge of general ENT anatomy and ENT surgery. Knowledge of assessing patients with ENT disorders such as hearing and balance disorders, head and neck tumors, sino-nasal and voice disorders. Knowledge of diagnostic ENT procedures (nasopharyngoscopy, otoscopy) and ENT surgical procedures. Knowledge of ENT medical devices (surgical instruments, implantable devices). Familiarity with FDA medical device regulatory processes and regulations (e.g., 21 CFR Part 874) and related guidances is preferred. Excellent written and verbal communication skills; ability to communicate effectively with a technical team. Strong interpersonal skills; able to work independently and as part of a multidisciplinary team (engineers, statisticians, biologists, etc.). This position is 100% telework. To attract qualified applicants, Tunnell strives to hire a diverse workforce and ensures all qualified applicants 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 onsite work requirements, and Tunnell employees and/or contractors are expected to comply with all client requirements, including safety and health protocols. Seniority level
Mid-Senior level Employment type
Full-time Job function
Health Care Provider Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Tunnell Government Services, Inc. by 2x.
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2 days ago Be among the first 25 applicants 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. FDA CDRH – Medical Officer (Otolaryngologist [ENT]) SME Position Description. The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, HDE and De Novo marketing applications, Pre-submissions, Investigational Device Exemptions, Recalls); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and otolaryngology, as relevant to medical devices. Responsibilities
Provide expert consulting services to assist the CDRH with regulatory responsibilities related to medical devices. Support medical device reviews and regulatory submissions (e.g., EUA, 510(k), PMA, HDE, De Novo). Participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders. Develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports. Perform other administrative office tasks related to CDRH projects. Requirements And Qualifications
The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. Current, active, full, and unrestricted medical license or registration to practice medicine in a U.S. state, District of Columbia, Puerto Rico, or a U.S. territory. At least fifteen (15) years of relevant clinical experience. Certification from a U.S. relevant specialty board organization (e.g., American Board of Otolaryngology – Head and Neck Surgery). Thorough understanding of current clinical practices in otolaryngology, including diagnosis and treatment, and current/emerging trends in practice. Knowledge of general ENT anatomy and ENT surgery. Knowledge of assessing patients with ENT disorders such as hearing and balance disorders, head and neck tumors, sino-nasal and voice disorders. Knowledge of diagnostic ENT procedures (nasopharyngoscopy, otoscopy) and ENT surgical procedures. Knowledge of ENT medical devices (surgical instruments, implantable devices). Familiarity with FDA medical device regulatory processes and regulations (e.g., 21 CFR Part 874) and related guidances is preferred. Excellent written and verbal communication skills; ability to communicate effectively with a technical team. Strong interpersonal skills; able to work independently and as part of a multidisciplinary team (engineers, statisticians, biologists, etc.). This position is 100% telework. To attract qualified applicants, Tunnell strives to hire a diverse workforce and ensures all qualified applicants 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 onsite work requirements, and Tunnell employees and/or contractors are expected to comply with all client requirements, including safety and health protocols. Seniority level
Mid-Senior level Employment type
Full-time Job function
Health Care Provider Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Tunnell Government Services, Inc. by 2x.
#J-18808-Ljbffr