Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and …
Skills: Medical Device Decontamination, Sterilization Validation, FDA Regulatory Review, 510(k) Submissions, ISO Standards
Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and …
Skills: Gastroenterology, Clinical Review, Medical Device Regulation, Endoscopy, Colonoscopy
\n \n $80,000 - $90,000 a year We are seeking experienced Registered Nurses to provide safe, compassionate care in an alcohol detox unit at the NIH Clinical Center. This is a 13-week contract assignment with the possibil…
Skills: Acute Care Nursing, Medical Surgical Care, Alcohol Detox, Patient Care, BLS
Leidos has a current opening for a TS/SCI cleared Database Administrator supporting our client’s overall mission to design and implement a data centric architecture that leverages cloud-based computing, artificial intell…
Location: West Bethesda, MD * This position is eligible for a $500 ZelTech Non-Employee Referral fee. Contact ZelTech Recruiters for questions concerning this matter. * Join Our Talent Community to Stay Connected! Job Su…
Electrical Engineer -MBSE-Power and Control System
Bethesda, Maryland, United States · On-site
$110k–$130k/yr
Mid level
Location: West Bethesda, MD * This position is eligible for a $500 ZelTech Non-Employee Referral fee. Contact ZelTech Recruiters for questions concerning this matter. * Join Our Talent Community to Stay Connected! Job Su…
Skills: Electrical Design, Model-Based Systems Engineering (MBSE), SysML, Cameo, Power Distribution
Locations: West Bethesda, MD * This position is eligible for a $500 ZelTech Non-Employee Referral fee. Contact ZelTech Recruiters for questions concerning this matter. * Join Our Talent Community to Stay Connected! Job S…
Skills: Naval Architecture, Hull Form Development, Hydrostatics, Seakeeping, Structural Analysis
Global Solutions Network, Inc.
Scientific Program Analyst - NIH
Bethesda, Maryland, United States · On-site
$92k–$119k/yr
Senior
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Skills: Program Management, Project Management, Scientific Research, Literature Review, Data Analysis
Position Summary This position is ONSITE in Bethesda, MD. National Capitol Contracting is seeking a highly organized and customer-focused AV Conference Services Event Planner to support the National Institutes of Health …
Join a Company Where Your Work Makes a Difference At ISN, we believe our people are the driving force behind our success. For more than 45 years, we've partnered with over 150 federal agencies to deliver innovative, miss…
Skills: Program Integrity, Compliance Management, Audit Execution, Records Handling, Information Protection
Join a Company Where Your Work Makes a Difference At ISN, we believe our people are the driving force behind our success. For more than 45 years, we've partnered with over 150 federal agencies to deliver innovative, miss…
Skills: Data Analysis, Performance Monitoring, Forecasting, Reporting, Program Coordination
Join a Company Where Your Work Makes a Difference At ISN, we believe our people are the driving force behind our success. For more than 45 years, we've partnered with over 150 federal agencies to deliver innovative, miss…
Join a Company Where Your Work Makes a Difference At ISN, we believe our people are the driving force behind our success. For more than 45 years, we've partnered with over 150 federal agencies to deliver innovative, miss…
Join a Company Where Your Work Makes a Difference At ISN, we believe our people are the driving force behind our success. For more than 45 years, we've partnered with over 150 federal agencies to deliver innovative, miss…
Description Job Description ProSource360 Consulting Services, Inc. is seeking an Acquisition Analyst to support the National Institute of Health (NIH). Assist in managing the simplified purchase order process while suppo…
Skills: Acquisition Planning, Contract Administration, Price/Cost Analysis, Federal Procurement, Market Research
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Do you enjoy applying your expertise in molecular biology to solve complex biological questions while improving the systems that manage scientificdata? Computercraft is seeking Genomic Data Curators/ Molecular Biologists…
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Director, Member Relations, The Pharmacy Technician Society (TPTS)
Bethesda, Maryland, United States · Hybrid
$130k–$160k/yr
Senior
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Skills: Governance, Board Support, Strategic Planning, Member Engagement, Professional Development
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Skills: Bioinformatics, Genomics, Molecular Biology, Computational Biology, Data Science
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Full-time
bachelor degree, postgraduate degree
Posted 50d ago
~40 hrs/week
Responsibilities
Provide expert regulatory and technical support to the FDA CDRH in reviewing medical device decontamination and sterilization submittals. This includes evaluating 510(k) submissions, conducting consultations, and developing detailed written reports and correspondence.
Requirements
Requires a bachelor's degree in a scientific/technical discipline and at least 15 years of direct experience in medical product decontamination and sterilization. Candidates must be US citizens or Green Card holders with an advanced understanding of sterilization technologies and FDA guidance.
Full job description
Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.
FDA CDRH – Medical Device Decontamination 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 of medical devices.
Responsibilities:
Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise, experience, and training in the field of decontamination/sterilization, as relevant to medical devices and device related combination products.
The primary focus of the role is to provide regulatory and technical support to CDRH in the review and disposition of submittals from the medical device decontamination/sterilization industry to include review of 510(k) submissions, consultations, Pre-Submission (Q-Sub) engagements, among others. The candidate will use a combination of technical and operational expertise along with extensive review of FDA guidance documents and standard test methods relevant to each product to conduct a review of each submission, with a goal of ensuring that the product is safe and effective
Participate in meetings and teleconferences, coordinate meetings with internal and external stakeholders related to marketing applications and pre-submissions
Support ancillary, prioritized activities in support of the agency, such as performing review of Medical Device Reporting (MDR) submittals
Develop written reviews and correspondence
Write detailed documents and reports
Skills and Qualifications:
The candidate must possess a bachelor’s degree (BS in a scientific/technical discipline applicable to sterilization/decontamination)
An advanced degree (MS, PhD) in a related/applicable field is strongly preferred.
At least 15 years of experience is required (direct experience in decontamination/sterilization involving medical products)
Experience with FDA Sterilization/Decontamination Guidance and other US regulatory requirements and consensus standards (ISO, ANSI) for medical devices highly preferred.
Candidate must be able to apply knowledge of decontamination/sterilization to the assessment of medical devices. This must entail an advanced understanding of the various techniques and industry best practices involving technologies to include fumigants, radiation, use of heat/steam, disinfectants, and validation approaches, e.g., indicators.
The ability to read and interpret standards, as well as knowledge of validation and testing methods related to sterilization, biocompatibility, shelf life, and performance testing, is critical.
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.
Must be a US Citizen or Full Green Card holder.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. 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.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
Related keywords
FDACDRHMedical DevicesDecontaminationSterilization510(k)Q-SubISOANSIFumigantsRadiationHeat/SteamDisinfectantsValidationBiocompatibilityShelf Life
Tunnell Consulting, Inc., has served the pharmaceutical industry as scientific and technical consultants for over 50 years. In 2008, the Company established Tunnell Government Services, Inc. (TGS) as a wholly owned subsidiary to focus exclusively on government sector support. TGS currently provides support in the medical research and product development arena within the DoD (USAMRMC and Navy), HHS (BARDA and NIH), DHS (HQs S&T) and other federal agencies across the Public Health Emergency Management Countermeasures Enterprise (PHEMCE). Not just a source of laboratory research and support personnel, TGS brings established experience in practices that adhere to FDA guidelines and industrial acceptance. Our offerings include: Medical Product Development; CBRN and Emerging Infectious Disease Public Health Preparedness; Warfighter Protection; Biomedical IT; Healthcare and Medical Product Engineering/Technology; and Human Capital/Organizational Excellence. TGS provides a wide diversity of functional experts, from Ph.D level Immunologists, Biochemists, Molecular Biologists, Toxicologists, Physiologists and Veterinarians, etc. to research associate, research technician, research nurse, chemist, microbiologist, biologist, Principal Investigator and physiologist. With this background of work, relevant experience in both work and organizations, and robust recruitment capability, we feel confident that we can meet and exceed the challenges of our diversified customer portfolio.
Offices: 6701 Democracy Blvd., Bethesda, MD 20817, US
Integrated Scientific and Biomedical ServicesMedical Product Development including CountermeasuresPublic Health and Security related to CBRNEmerging Infectious DiseasesPandemic Influenzaand FDA and Clinical SupportBiotechnology
How much do Government & Public Sector jobs in Bethesda, MD pay?
Based on 328 listings with disclosed salaries, most government & public sector jobs in Bethesda, MD pay between $70k–$195k per year. Individual offers vary with seniority, company size, and specialization.
How many Government & Public Sector jobs are open in Bethesda, MD right now?
There are currently 454 open government & public sector positions in Bethesda, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Government & Public Sector roles in Bethesda, MD?
Companies currently hiring include Leidos, Guidehouse, CACI International Inc, General Dynamics Information Technology, Global Solutions Network, Inc., among others. Browse the listings above to see every active employer.
Are there remote or hybrid Government & Public Sector jobs in Bethesda, MD?
Yes — 147 of the 454 open government & public sector positions offer remote or hybrid work (36 remote, 111 hybrid).
How do I apply for Government & Public Sector jobs in Bethesda, MD?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.