Bethesda, Maryland, United States · Remote Solely
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: Regulatory Affairs, Medical Device Review, Clinical Trial Design, Biostatistics, Real-world Evidence
Bethesda, Maryland, United States · On-site
WHY YOU'LL LOVE WHAT YOU DO AT PLANTA: Medical, Dental, Vision & Life Insurance offered for PLANTA employees. Work/life balance is a priority — annual PTO starts 90 days after date of employment. No limit on referr…
Skills: Staff training, Inventory management, Cost control, Operations management, Problem solving
Bethesda, Maryland, United States · On-site
$175k–$205k/yr
Job Summary: We are seeking an entrepreneurial, high-autonomy Associate Director of Communications & Public Relations to serve as the strategic architect and hands-on leader of our external and internal messaging. This i…
Skills: Strategic communications, Public relations, Media relations, Corporate messaging, Executive communications
Bethesda, Maryland, United States · Hybrid
$73k–$122k/yr
Job Summary: Love organization, problem-solving, and keeping complex legal matters on track? At Centrus Energy, you'll play an important role supporting the legal team that's helping power the future of clean energy. As …
Skills: Contract management, Corporate records maintenance, Compliance activities, Litigation support, Legal documentation
Bethesda, Maryland, United States · On-site
$85k–$105k/yr
Job Summary: Strong financial reporting and disciplined accounting practices are essential to every successful organization. As a Senior Accountant, Corporate Accounting at Centrus Energy, you’ll play a critical role in …
Skills: Financial reporting, General ledger accounting, Account reconciliations, Month-end close, U.S. GAAP
Marriott International Hotels, Inc.Bethesda, Maryland, United States · Remote OK
$22/hr–$39/hr
FLEX is a temporary full-time position with an initial assignment of one year and the possibility of extension based on performance and business needs. This is a remote position to support hotels in the East region. Pref…
Skills: Recruiting Coordination, Applicant Tracking Systems, Candidate Screening, Interview Scheduling, Pre-employment Screening
San Francisco, California, United States · Remote OK
$164k–$257k/yr
ZoomInfo is where careers accelerate. We move fast, think boldly, and empower you to do the best work of your life. You’ll be surrounded by teammates who care deeply, challenge each other, and celebrate wins. With tools …
Skills: Distributed systems, Java, Go, Python, SQL
Bethesda, Maryland, United States · Hybrid
$140k–$220k/yr
ZoomInfo is where careers accelerate. We move fast, think boldly, and empower you to do the best work of your life. You’ll be surrounded by teammates who care deeply, challenge each other, and celebrate wins. With tools …
Skills: Node.js, Angular, Java, Microservices, RESTful API
Bethesda, Maryland, United States · Hybrid
$140k–$220k/yr
ZoomInfo is where careers accelerate. We move fast, think boldly, and empower you to do the best work of your life. You’ll be surrounded by teammates who care deeply, challenge each other, and celebrate wins. With tools …
Skills: Node.js, Angular, Java, Microservices, RESTful API
Marriott International Hotels, Inc.Bethesda, Maryland, United States · Hybrid
$110k–$159k/yr
JOB SUMMARY The Senior Manager, Travel Insurance and Financial Protection Program will lead the day-to-day management, performance, and growth of Marriott’s Travel Insurance and Financial Protection Programs. Reporting t…
Skills: Program management, Project management, Strategic planning, Stakeholder management, Vendor management
H&R BlockBethesda, Maryland, United States · On-site
About the Role As a seasonal Tax Advisor at H&R Block, you are a trusted advisor who helps clients navigate complex tax situations with confidence. You'll use your expertise to prepare accurate returns, uncover savings o…
Skills: Tax preparation, Accounting, Finance, Bookkeeping, Client relations
Bethesda, Maryland, United States · On-site
$80k–$150k/yr
Your Future Team Hightower Bethesda Wealth Management is a fiduciary fee-only practice in Bethesda, Maryland. Our comprehensive approach covers the full spectrum of wealth management, including investing, financial plann…
Skills: Tax planning, Wealth management, Financial planning, Tax mitigation, Data analysis
Westport, Connecticut, United States · Hybrid
$120k–$140k/yr
About this Opportunity: At Regency Centers, our people are our greatest asset, and we believe that our highly skilled and talented team makes us better. We are seeking a Manager of Financial Services to join either our W…
Skills: Financial Modeling, Underwriting, Due Diligence, Argus, Excel
Bethesda, Maryland, United States · On-site
$34/hr–$42/hr
The Quality Engineer will evaluate and/or appraise supplier's manufacturing capabilities to baseline their processes for conformance to various documented commodity checklists, and/or QMS special processes. Establishes p…
Skills: Quality engineering, Lean manufacturing, Six-sigma, FMEA, SPC
Bethesda, Maryland, United States · On-site
$115k–$170k/yr
Overview Donohoe Construction Company is seeking a highly motivated Senior Project Manager to join our New Construction team. Our Senior Project Managers are primarily responsible for evaluating construction progress and…
Skills: Construction management, Project management, Estimating, Scheduling, Budgeting
Newark, Delaware, United States · Hybrid
$75k–$80k/yr
Join Aledade as a Practice Transformation Specialist (PTS) and personally make an impact on patient care. Practice Transformation Specialists are HQ’s most direct interface with providers and can glean valuable insight i…
Skills: Practice management, Population health, Electronic health records, Project management, Process mapping
Bethesda, Maryland, United States · Hybrid
$152k–$236k/yr
Why Join GEICO? At GEICO, we offer a rewarding career where your ambitions are met with endless possibilities. Every day we honor our iconic brand by offering quality coverage to millions of customers and being there whe…
Skills: Employment law, Employee benefits, ERISA, Internal Revenue Code, Affordable Care Act
Bethesda, Maryland, United States · On-site
$28/hr
Brandan Enterprises Inc. (BEI) is seeking applications for the position of Administrative Assistant II to provide administrative support at the National Institute of Health in Bethesda, MD. Duties: Administrative Assista…
Skills: Administrative support, Clerical skills, Patient scheduling, Data entry, Communication skills
Bethesda, Maryland, United States · On-site
$100k–$130k/yr
Overview Donohoe Construction Company is seeking a highly motivated Superintendent to join our New Construction team. Who We Are Established in 1884, Donohoe is the Washington, DC region’s oldest full-service real estate…
Skills: Construction management, Project scheduling, Quality control, Safety program enforcement, Subcontractor management
Bethesda, Maryland, United States · On-site
$100k–$110k/yr
Overview Donohoe Construction Company is seeking a highly motivated Project Manager to join our New Construction team. Who We Are Established in 1884, Donohoe is the Washington, DC region’s oldest full-service real estat…
Skills: Project management, Construction management, Estimating, CPM scheduling, Financial forecasting
Bethesda, Maryland, United States • Remote Solely
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The reviewer will evaluate pre-market submissions and lifecycle applications for combination medical products to ensure safety and regulatory compliance. They will also collaborate with cross-center experts to provide regulatory feedback and draft formal deficiency letters for manufacturers.
Candidates must possess a bachelor's degree in a relevant field, with an advanced degree preferred, and 5-7 years of applicable regulatory or scientific experience. Proficiency in FDA regulatory standards, clinical trial evaluation, and strong communication skills are essential for this role.
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.
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.
The Office of Clinical Evidence and Analysis within CDRH's Office of Product Evaluation and Quality (OPEQ) provides policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders.
Tunnell Government Services, Inc. is providing professional and scientific services to CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; write detailed documents and reports; and execute other administrative tasks related to CDRH’s projects.
Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities, specific to the evaluation of pre-market submissions and lifecycle applications for medical products that combine medical devices with drugs and/or devices (e.g., drug-eluting stents, pre-filled syringes, inhalers).
This candidate should possess specific expertise and applicable training in regulatory scientific review, as relevant to:
Key Duties and Responsibilities
Qualifications
Job Type: Full Time
Schedule: Monday through Friday (No Holidays)
Location: This position is 100% telework.
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.
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
