Regulatory Medical Device Advisor

US-MD-Frederick
7 days ago
Company
Noblis ESI
Requisition #
5766
FT/PT/On-Call
Full Time
Security Clearance
Secret
Job Category
Biology and Chemistry

Overview

Why work at a Noblis company?
Our employees find greater meaning in their work and balance the other things in life that matter to them. Our people are our greatest asset. They are exceptionally skilled, knowledgeable, team-oriented, and mission-driven individuals who want to do work that matters and benefits the public.

Noblis has won numerous workplace awards. Over the past two decades, Noblis has consistently earned wide recognition:
1. Best Employer: We have been a Washington Post “Top Workplace” for 4 consecutive years including the last three among the top 10. We’ve also been recognized by Glassdoor “Best Medium-Sized Company to Work For” for 2 years, and many awards in previous years
2. Business Ethics and Integrity: A “World’s Most Ethical Company” for 6 years by Ethisphere Institute, Finalist at the Greater Washington Government Contractor Awards
3. Leadership and Innovation: CEO Amr ElSawy and SVP National Security Roger Mason selected to Executive Mosaic’s annual Wash 100 List, CEO Amr ElSawy named as a “Tech Titan” by the Washingtonian Magazine, Noblis CTO recognized as a trending 40 CIO in the DC Area.

 

Noblis maintains a drug-free workplace and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race.

Overall Program Summary:

 

The Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) has a mission to provide protection from weapons of mass destruction by generating affordable capabilities. In support of this mission, the Medical Countermeasure Systems (MCS) was established in 2013 “to facilitate the advanced development and acquisition of safe, effective and innovative medical solutions and systems that combat Chemical, Biological, Radiological, Nuclear (CBRN) threats, Emerging Infectious Diseases (EIDs), and protect and preserve the lives of our operating forces. The Medical Countermeasure Systems provides new and improved medical countermeasures that address CBRN and EID threats.” (Medical Countermeasure Systems, n.d.)

 

Responsibilities

In this role, Medical Device Advisor:

  • Participate in product development teams. 
  • Ensure all areas specific to device manufacture are in the right development order and appropriate for the development effort. 
  • Review on-going technical efforts to assess appropriateness and identify gaps in the current device design and manufacturing development pathway. In addition, the contractor shall report on appropriateness and gaps in device design and manufacturing. 
  • Support FDA submission of auto-injectors. As part of this task, the contractor shall:
    • Evaluate the adequacy of human factors and functional testing to determine the appropriateness of studies (i.e., methodology, conduct, and reporting) 
    • Ensure that studies will meet FDA requirements 
    • Report on the results found
  • Monitor and report on the standards employed by auto-injector manufacturers and how the standards are employed in the development or production of auto-injectors. 
  • Prepare reports to evaluate the use and completion of risk assessment and problem-solving techniques by companies developing auto-injectors. 
  • Review and report on Design History Files supporting combination products, including auto-injectors, to assure they are current, robust, and meet all FDA, ASTM, American National Standards Institute (ANSI), and ISO requirements.  
  • Provide input and assist in the development of regulatory strategies, target product profiles, and other regulatory documents related to the design, manufacture, and assembly of the device, obtaining input from subject matter experts as needed. 
  • Review regulatory strategies related to technical manufacturing for accuracy and consistency.  
  • Evaluate Department of Defense (DoD) acquisition documents that include FDA regulatory requirements or impact the drug development timeline.  
  • Review and provide written feedback technical records generated during the development process for accuracy and adequacy.  
  • Evaluate change control documentation to determine product impact.  
  • Evaluate contract proposals specific to the manufacturing development plan.  
  • Ensure that protocols, data collection forms, and subsequent study reports are consistent and accurate, and that data support stated results.  
  • Conduct on-site visits to ensure that data collected is supported by the raw data. The contractor shall prepare a report after each visit, to be shared with the entire development team, to convey observations made and how site procedures comply with applicable standards and/or regulations.  
  • Evaluate the testing facility, ensuring that its personnel and equipment meet minimum requirements identified within FDA combination product regulations and guidance documents.  
  • Maintain interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge across and within organizations united for the development of medical countermeasures.

 

 

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