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.
- ...Senior Regulatory Affairs SME | Healthcare and Life Sciences ProSidian is seeking... ...Staffing Support Services in the medical countermeasures field of... ...diagnostics, medical devices, vaccines, and therapeutics... ...initiatives. Extensive FDA engagement experience, including...SeniorMedical deviceFull timeTemporary workFor contractorsWork at officeFlexible hours
- ...the industry's leading scientists, medical and technical experts, and human capital... ...for you and contact us. Sr. Regulatory Affairs SME - Medical Devices Background: A Regulatory Affairs... ...are products which are regulated by FDA's Center for Devices and Radiological...SeniorMedical deviceContract workFor contractors
- ...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
- ...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
- ...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... ...assist the CDRH with their regulatory responsibilities. This...Medical deviceFor contractorsWork at officeRemote work
- ...Senior Radiological/Nuclear SME | Healthcare and Life Sciences ProSidian is a Management... ...of interest within the Medical Countermeasures field of... ..., manufacture, and regulatory approval/ licensure/ clearance... ...diagnostics and other medical devices/infrastructure vaccines...SeniorMedical deviceFull timeContract workFor contractorsWork at office
- ...Senior Nonclinical Models SME | Healthcare and Life Sciences ProSidian... ...interest within the Medical Countermeasures... ...development, manufacture, and regulatory approval/ licensure/... ...and other medical devices/infrastructure... ...models to support U.S. FDA approval or...SeniorMedical deviceFull timeContract workFor contractorsWork at office
- ...Senior Decentralized Clinical Care SME | Healthcare and Life Sciences ProSidian is a... ...areas of interest within the Medical Countermeasures field of... ..., manufacture, and regulatory approval/ licensure/ clearance... ...diagnostics and other medical devices/infrastructure vaccines...SeniorMedical deviceFull timeContract workFor contractorsWork at office
$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- Tunnell Government Services, Inc. seeks a Medical Officer specializing in neurology to provide expert consulting for the FDA Center for Devices and Radiological Health. The role includes supporting medical device reviews and coordinating with various stakeholders. Applicants...Medical 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
$94k - $150k
...Senior Regulatory Affairs Specialist, Ultrasound The Senior Regulatory Affairs Specialist for Ultrasound... ...documents for agencies such as the FDA, Health Canada, EU Competent... ...Files, Declarations of Conformity, and Medical Device Licenses—for various global markets....SeniorMedical deviceFull timeWork at officeLocal areaWork visaRelocation package3 days per week- ...an Engineering Manager, Product Development. This remote position focuses on leading a technical team to develop medical devices, ensuring compliance with FDA and ISO standards. The ideal candidate will have over 8 years of experience in medical device engineering,...Medical deviceRemote 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- ...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
$260k - $365k
...FDA + Healthcare Regulatory Associate Attorney Location: Washington, DC Direct Counsel is seeking an FDA + Healthcare Regulatory Associate... ..., dietary supplement, pharmaceutical, biotechnology, medical device, cosmetic, and healthcare technology industries. The...Medical deviceFlexible hours- ...with a V10 firm's ranked Healthcare and FDA group on an unposted need in the DC office... ...group represents clients in healthcare regulatory and transactional matters, including... ...FDA. Clients include pharmaceutical and medical device manufacturers, healthcare and technology...Medical deviceWork at office
- ...Washington, D.C. office of Hogan Lovells is seeking a junior to mid-level associate to join their Medical Devices group. This role involves advising clients on FDA regulatory matters throughout the lifecycle of medical device regulation, including premarket applications...Medical deviceWork at office
- 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
- 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
- ...Technical Surveillance Countermeasures Specialist SME Xcelerate Solutions is seeking a Technical Surveillance Countermeasures... ...instruction at Agency and ICD level Evaluate and recommend medical device approval or mitigation strategy Conduct radio frequency direction...Medical device
- A leading tobacco company in Washington, D.C. seeks a Senior Counsel, Regulatory to provide legal advice on FDA regulatory matters for smoke-free products. This role involves advising on market research compliance and state regulatory applications. Candidates should have...Senior
- 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
$131.3k - $237.35k
Leidos Inc is hiring a SCRM Analyst SME in Alexandria, Virginia. This role focuses on enhancing and delivering enterprise data and analytics... ...project management, demonstrating their ability to work with senior government customers. The salary range is $131,300.00 - $237,350...Senior- Overview The Director, Regulatory Science and Policy, works closely... ...Science Policy and Government Affairs (and Chief Policy Officer)... ...in areas that are focused on FDA‑related issues. The... ...for prescription drugs and medical devices. The Director, Regulatory Science...Medical deviceWork at office
- 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
$235k - $310k
...junior to mid-level associate to join the Medical Devices group within our Food, Drug, Medical... ...compliance, enforcement, and strategic regulatory matters. Position Overview Our Medical... ...States, we have been advising companies on FDA regulatory matters for decades,...Medical deviceWork at officeWorldwideRelocation package- cFocus Software Incorporated is seeking a Cybersecurity Operations Technical Lead (SOC Engineer/SME) in Washington, DC. This role involves providing technical leadership for SOC operations, managing cybersecurity monitoring and incident response, and ensuring compliance...Senior
- ...experience in both patent prosecution and litigation. Experience with patents in the biotechnology, pharmaceutical, gene therapy, medical device and digital health industries. Knowledge of patent portfolio management and development, competitive landscape analyses, and...SeniorMedical deviceWork at office
- ...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
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