Tunnell Government Services, Inc.
Medical Officer (Pulmonologist)
Tunnell Government Services, Inc., Bethesda, Maryland, us, 20811
Overview
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.
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 pulmonology, as relevant to medical devices.
Responsibilities
Provide expert consulting services to assist CDRH with regulatory responsibilities related to medical devices.
Support 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 duties related to CDRH’s projects.
Possess specific expertise and training in clinical medicine and pulmonology, as relevant to medical devices.
Requirements and Qualifications
The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
Must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
At least fifteen (15) years of relevant clinical experience.
Certification from a U.S. relevant specialty board organization (e.g., American Board of Internal Medicine (ABIM), American Association for Bronchology and Interventional Pulmonology (AABIP), etc.).
Thorough understanding of current clinical practices in pulmonology, including diagnosis and treatment, and current/emerging trends in practice.
Knowledge of lung physiology and ventilation modalities.
Knowledge of evaluation of patients with a wide variety of respiratory symptoms and conditions (e.g., asthma, COPD, interstitial lung disease, lung cancer).
Knowledge of pulmonary diagnostics, procedures and interventions including bronchoscopy.
Knowledge of diagnosing and managing lung infections, sleep apnea, pulmonary hypertension, and cystic fibrosis.
Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 870 – Subchapter H: Medical Devices), and guidances is preferred.
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 (e.g., engineers, statisticians, biologists).
Work Arrangement This position is 100% telework.
EEO Statement 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. 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.
Please be advised that 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.
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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 pulmonology, as relevant to medical devices.
Responsibilities
Provide expert consulting services to assist CDRH with regulatory responsibilities related to medical devices.
Support 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 duties related to CDRH’s projects.
Possess specific expertise and training in clinical medicine and pulmonology, as relevant to medical devices.
Requirements and Qualifications
The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
Must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
At least fifteen (15) years of relevant clinical experience.
Certification from a U.S. relevant specialty board organization (e.g., American Board of Internal Medicine (ABIM), American Association for Bronchology and Interventional Pulmonology (AABIP), etc.).
Thorough understanding of current clinical practices in pulmonology, including diagnosis and treatment, and current/emerging trends in practice.
Knowledge of lung physiology and ventilation modalities.
Knowledge of evaluation of patients with a wide variety of respiratory symptoms and conditions (e.g., asthma, COPD, interstitial lung disease, lung cancer).
Knowledge of pulmonary diagnostics, procedures and interventions including bronchoscopy.
Knowledge of diagnosing and managing lung infections, sleep apnea, pulmonary hypertension, and cystic fibrosis.
Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 870 – Subchapter H: Medical Devices), and guidances is preferred.
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 (e.g., engineers, statisticians, biologists).
Work Arrangement This position is 100% telework.
EEO Statement 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. 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.
Please be advised that 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.
#J-18808-Ljbffr