Medical Officer (Pulmonologist)

TUNNELL GOVERNMENT SERVICES in; Bethesda (MD); Remote; USD 200,000 - 300,000; Full time

Job summary

A consulting firm specializing in regulatory services is seeking a Medical Officer (Pulmonologist) to provide expert consulting for the FDA's CDRH. The ideal candidate must have a Doctor of Medicine degree, at least 15 years of clinical experience, and knowledge of pulmonary diagnostics and FDA processes. This position is 100% telework, offering flexibility while contributing to public health by ensuring the safety and efficacy of medical devices.

Qualifications

• Minimum of 15 years of relevant clinical experience.
• Certification from a relevant U.S. specialty board organization.
• Understanding of current clinical practices in pulmonology.

Responsibilities

• Provide expert consulting services to assist CDRH in regulatory responsibilities.
• Support medical device reviews and regulatory processes.
• Perform research and conduct data analysis as needed.

Skills

Clinical medicine expertise

Pulmonology knowledge

Excellent communication skills

Interpersonal skills

Education

Doctor of Medicine (M.D.) or equivalent

Current, active medical license

Job description

FDA CDRH – Medical Officer (Pulmonologist) 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 and 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.

Requirements and Qualifications

• 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.
• 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.
• 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.).

This position is 100% telework.