Senior Regulatory Affairs SME - Medical Devices & FDA
Tunnell Government Services, Inc.
Tunnell Government Services, Inc. is looking for a Sr. Regulatory Affairs Subject Matter Expert to provide vital regulatory support to BARDA in Bethesda, MD. The candidate will leverage extensive experience in device development and regulatory affairs, especially in the area of diagnostic devices. Key responsibilities include ensuring compliance with FDA regulations, providing guidance on submissions, and collaborating with cross-functional teams. Ideal candidates must possess a strong background in life sciences and communication skills, with a minimum of 15 years' experience in the field. #J-18808-Ljbffr Tunnell Government Services, Inc.
- ...industry's leading scientists, medical and technical experts, and... ...for you and contact us. FDA CDRH - Urology SME Position Description... ...mission of the FDA Center for Devices and Radiological Health (CDRH... ...assist the CDRH with their regulatory responsibilities. This...Medical deviceFor contractorsRemote work
- Sr. Regulatory Affairs SME - Medical Devices Background A Regulatory Affairs Analyst/subject matter expert is needed to provide contracted staffing support... ...technologies. These are products which are regulated by FDA's Center for Devices and Radiological Health (CDRH) and/...SeniorMedical deviceContract workFor contractors
- ...on a wide variety of legal and regulatory matters. Our practitioners... ...Act, Anti-kickback, Stark, and FDA disputes and investigations. We... ...investigations through the evaluation of medical records, the determination of... ...as pharmaceutical and medical device manufacturers. We will...SeniorMedical deviceWork at officeRemote work
- ...Church School is seeking a Sr. Regulatory Affairs SME for the Biomedical Advanced Research... ...regulatory expertise for medical countermeasures and compliance with FDA regulations. Candidates should have... ...over 15 years of experience in device development, substantial knowledge...SeniorMedical device
$126k - $178k
...lasting relationships with medical professionals and... ...transform patient care with devices supported by clinical... ...objective of the Senior Product Manager, Field... ...on clinical evidence, FDA regulatory approvals, and market... ...marketing, and medical affairs teams to ensure integrated...SeniorMedical deviceWork experience placementWork at officeRemote workNight shift- ...industry's leading scientists, medical and technical experts, and... ...for you and contact us. FDA Veterinary Medical SME Position Description... ...technical data included in regulatory submissions, as relevant to... ...regulatory review of medical devices. Such submissions include Premarket...Medical deviceFull timeFor contractorsWork at officeRemote workMonday to Friday
- ...s leading scientists, medical and technical experts,... ...specifically the Division of Regulatory and Quality Affairs: Essential duties... ...matter expert (SME). Provide assessments... ...manufacture. Experience with device and/or IVD development, including FDA Quality Management...Medical deviceFor contractors
- ...industry's leading scientists, medical and technical experts, and... ...for you and contact us. FDA CDRH - Ophthalmology SME Position Description The... ...of the FDA Center for Devices and Radiological Health (CDRH... ...the CDRH with their regulatory responsibilities. This candidate...Medical deviceFor contractorsWork at officeRemote work
$183k - $228.8k
ZEISS Meditec Inc. is looking for a Senior Advisor in Regulatory and Clinical Affairs in Washington, DC. The role... ...guiding regulatory strategy for FDA submissions and collaborating on clinical research for innovative medical devices. Candidates should have a master'...SeniorMedical deviceRemote job- ...industry's leading scientists, medical and technical experts,... ...you and contact us. FDA CDRH - Medical Officer (Plastic Surgeon) SME Position Description... ...mission of the FDA Center for Devices and Radiological Health... ...the CDRH with their regulatory responsibilities. This...Medical deviceFor contractorsWork at officeRemote work
$183k - $228.8k
...Industrial Quality & Research, Medical Technology, Consumer... ...What’s the role? This Senior Advisor, Regulatory and Clinical Affairs, US is responsible for guiding... ...support of a variety of FDA submissions including pre... ...) and investigational device exemptions (IDEs). In addition...SeniorMedical deviceLocal areaRemote work- ...Search seeks a mid-level associate for its Washington, DC office. This role requires a minimum of 4 years of experience to support FDA regulatory matters in the life sciences sector. The associate will engage in strategic counseling, draft regulatory submissions, and...Medical deviceWork at office
- ...Junior to Mid-Level Associate for its Medical Devices group. This position involves advising... ...on medical device regulation, preparing FDA submissions, and managing compliance matters... ...should have an interest in FDA regulatory law, a law degree, and be admitted to the...Medical device
- Tunnell Government Services, Inc. is looking for a Medical Officer (Neurology) SME to support the FDA's Center for Devices and Radiological Health. This role entails providing expert consulting services, conducting data analysis, and supporting medical device reviews, all...Medical deviceRemote job
$235k - $310k
...seeks a junior to mid-level associate for its Medical Devices group. This role entails guiding clients through FDA regulations and managing compliance issues in a... ...practice. Responsibilities include advising on regulatory pathways, supporting premarket applications, and...Medical deviceWork at office- ...Job Title: Health Care & Policy / FDA - Associate Practice Area: Health Care & Life Sciences... ...Key Responsibilities Advise clients on complex regulatory compliance issues relating to drugs and medical devices. Provide guidance on matters involving...Medical deviceFull timeImmediate start
- ...Engineer to join our team and enhance patient care through modern medical devices. This role involves designing, developing, and maintaining... ...Master’s degree in Biomedical Engineering, and expertise in regulatory requirements. A comprehensive benefits package including...SeniorMedical device
- ...Director, Regulatory Science And Policy The Director, Regulatory... ...Science Policy and Government Affairs to implement a wide range of... ...areas that are focused on FDA-related issues. The Director... ...for prescription drugs and medical devices. The Director, Regulatory...Medical deviceWork at office
- A leading engineering company in Bethesda, MD is seeking a motivated Biomedical Engineer to develop and maintain medical devices aimed at enhancing patient care. The ideal candidate will hold a Master’s degree in Biomedical Engineering and have over 20 years of experience...SeniorMedical deviceRemote job
- ...practice in Washington, DC. The team advises life sciences companies on U.S. Food and Drug Administration (FDA) regulatory matters involving drugs, biologics, medical devices, and combination products. The role involves strategic counseling across the FDA medical product...Medical device
- Lexical Intelligence in Bethesda, MD is seeking a Senior Scientist / Engineer specializing in Oncology and Medical Devices. This role involves advancing R&D programs and conducting thorough technical evaluations to align with health outcomes. Candidates should possess...SeniorMedical device
- EmergencyMD is seeking a Program Manager (Acquisition SME) in Washington, DC, to lead the full lifecycle management of Defense Business... ...include managing contract operations, ensuring regulatory compliance, and implementing Agile frameworks. Preferred qualifications...SeniorContract work
- ...inclusive workplace, and commitment to their communities. FDA + Healthcare Regulatory and Compliance Practice Group They advise clients in the... ...pre-product launch to post-market representation in the medical device, pharmaceutical, food and dietary supplement,...Medical deviceFlexible hours
- ...is looking for a skilled professional to support analyses of medical devices in Bethesda, Maryland. This role involves coordinating with... ...writing detailed documents, and providing consultation for regulatory submissions related to biomedical engineering. The ideal candidate...Medical deviceRemote jobFlexible hours
- Bluemont Technology & Research, Inc. is looking for a Research Subject Matter Expert (SME) specializing in biometric sensors. In this role, you will lead the development and evaluation of advanced sensing technologies while collaborating with multidisciplinary teams. The...Senior
- ...experienced expert consultant in ophthalmology to assist the FDA CDRH. This fully remote role requires a Doctor of Medicine with... ...interpersonal and communication skills, familiarity with ophthalmic medical devices, and a deep understanding of current clinical practices in...Medical deviceRemote job
$130k
...Koniag IT Systems, LLC, a Koniag Government Services company , is seeking a Senior Management Analyst (SME)with a Secret security clearance to support KITS and our government customer in Arlington, VA. This position is for a Future New Business Opportunity. This is...SeniorFor contractorsWork at officeLocal areaFlexible hours$95k
...technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose... ...TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce...Medical deviceMinimum wageOngoing contractWork at officeLocal areaRemote workWorldwideRelocationWeekend workAfternoon shift- Senior Scientist / Engineer (Oncology / Medical Device) Lexical Intelligence provides software and services related to processing large-scale biomedical... ...program management, diagnostic device development, and regulatory affairs in diagnostics. The Senior Scientist / Engineer...SeniorMedical deviceTemporary workWork at officeLocal area
- A leading technology firm is seeking a Technical SME in Washington, DC to support the Department of Veterans Affairs' Electronic Health Record Modernization program. This role involves advising on technical matters, resolving complex integration issues, and ensuring systems...SeniorRemote job
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