FDA · 19 hours ago
Physician (Orthopedic Surgeon)
Silver Spring, MD
Full-time
Remote
Senior Level
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Responsibilities
Serve as an authority on the latest developments in health care policy and the orthopedic medical device industry.
Conduct regulatory policy reviews related to the development aspects of orthopedic medical devices, diagnostic equipment, surgical instrumentation, and systems used in this medical device space.
Provide oral and written consultations for various types of regulatory submissions across a wide range of orthopedic medical device types related to fracture fixation, joint replacement, reconstruction, trauma, sports medicine, limb lengthening, and disorders of the spinal, hand, and upper and lower extremities.
Foster patient partnerships with capabilities to collaborate with MedTech industry sponsors, innovators, and FDA to provide insights on unmet needs, disease burden, real world experiences and preferences within the target patient population.
Utilize clinical expertise and technical knowledge to serve as an authoritative voice and principal advisor to OHT 6 Assistant Directors and the OHT6 Office Director on matters regarding orthopedic medical devices, diagnostic equipment, instrumentation, surgical systems, and products, encompassing the entire product lifecycle.
Provide authoritative analysis of the scientific data submitted in orthopedic medical device regulatory submissions and assists in the interpretation of post-market adverse event data.
Offer evidence-based recommendations regarding classification and petitions for the reclassification of new orthopedic medical devices, instrumentation, and systems, as well as identifies areas where standards need to be developed and/or revised.
Qualification
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Required
Medical degree (MD or DO) with a specialization in Orthopedic Surgery.
Board certification in Orthopedic Surgery.
Extensive knowledge of orthopedic medical devices, diagnostic equipment, surgical instrumentation, and systems.
Experience in regulatory policy reviews related to orthopedic medical devices.
Strong oral and written communication skills for consultations on regulatory submissions.
Ability to foster partnerships with patients, MedTech industry sponsors, and FDA stakeholders.
Clinical expertise and technical knowledge in orthopedic medical devices and systems.
Experience in analyzing scientific data submitted in orthopedic medical device regulatory submissions.
Ability to provide evidence-based recommendations regarding classification and reclassification of orthopedic medical devices.
Company
FDA
The Food and Drug Administration is an agency within the Department of Health and Human Services.
Founded in 1906
10,001+ employees
Funding
Current Stage
Late StageLeadership Team
Bakul Patel
Director, Digital Health Center of Excellence - US FDA
D
Daniel Walter
Consumer Safety Officer
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