Medical Officer; Pulmonologist

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The mission of Tunnell Government Services, Inc. is to provide professional and scientific services to the FDA CDRH with expert consultants in medical devices regulation and approvals. This role supports regulatory responsibilities for medical devices and requires expertise in clinical medicine and pulmonology as relevant to medical devices.

Responsibilities

• Provide expert consulting services to assist the CDRH with regulatory responsibilities related to medical devices (e.g., EUA, 510(k), PMA, HDE and De Novo, Pre-submissions, Investigations, 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 projects.

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 as a Physician to practice medicine in a 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., ABIM, AABIP).
• Thorough understanding of current clinical practices in pulmonology, including diagnosis, treatment, and emerging trends.
• Knowledge of lung physiology and ventilation modalities.
• Knowledge of evaluation of patients with respiratory symptoms and conditions (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) and guidances is preferred.
• Excellent written and verbal communication skills; ability to work independently and in a team with technical personnel.

Note

This position is 100% telework.

EEO Statement
:
Tunnell strives to hire and retain qualified talent. 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. Certain client contracts may outline onsite requirements, and employees/contractors are expected to comply with client safety and health protocols.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Health Care Provider
• Industries:
  Religious Institutions