Tunnell Government Services, Inc. · 2 months ago
Medical Officer (Pulmonologist)
Bethesda, MD
Full-time
Onsite
Senior Level, Lead/Staff
15+ years expTunnell Government Services, Inc. is comprised of leading scientists and medical experts, committed to helping clients achieve strategic goals. They are seeking a Medical Officer (Pulmonologist) to provide expert consulting services to assist the FDA CDRH with their regulatory responsibilities, focusing on medical device reviews and related consultations.
Biotechnology
Responsibilities
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
Execute other administrative office tasks related to CDRH’s projects
Qualification
Required
The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States
In addition, the candidate 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., the 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, including asthma, COPD, interstitial lung disease, and 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
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 (i.e., engineers, statisticians, biologists, etc.)
Preferred
Familiarity with FDA medical device regulatory processes, regulations (e.g., relevant sections of 21 CFR Part 870 – Subchapter H: Medical Devices), and guidances is preferred
Company
Tunnell Government Services, Inc.
Tunnell Consulting, Inc., has served the pharmaceutical industry as scientific and technical consultants for over 50 years.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase