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Job Title: Regulatory Affairs Specialist
Job Number: 1901-63533-RAS-01
Organization: IHRC, Inc.
Posted: 2/13/2019
Type: Full-Time
Classification:
Industry:
Number of Openings: 1
Location: Atlanta,  GA    USA
Compensation: Commensurate with qualifications and experience
Position Description:

JOB TITLE: Regulatory Affairs Specialist

POSITION NUMBER: 1901-63533- RAS-01

POSITION LOCATION: Atlanta, GA, USA

ANTICIPATED START DATE: Two weeks after candidate identification

TRAVEL:  As required to fulfill the responsibilities of the position

IHRC, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to the Centers for Disease Control and Prevention (CDC) and other Federal and private sector clients.  The successful candidate will be assigned to the Laboratory Preparedness and Response Branch (LPRB), Division of Preparedness and Emerging Infections (DPEI), National Center for Emerging and Zoonotic and Infectious Diseases (NCEZID), at the Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, Atlanta, GA.  The selected candidate will provide regulatory support for the development and deployment of quality assays and products to LRN member laboratories, and the enhancement of existing and next generation assay development research activities, and the public health capacity of the LPRB.

The mission of the LPRB is to develop and validate new technologies for rapid identification of unknown samples, to provide rapid assays to the Laboratory Response Network (LRN), and to support the LRN with technical expertise in all assays deployed to the LRN through:

  • Developing, evaluating, and validating rapid methods for identification of bacterial agents using advanced technologies
  • Developing extraction methods for various sample types to facilitate rapid identification of bacterial agents in environmental and clinical samples
  • Providing training and consultation on technical issues associated with LRN protocols
  • Overseeing the development and deployment of new methods and technologies by the LRN technical review committee (TRC)
  • Establishing procedures for Performance, Production, Quality Assurance (QA) and Quality Control (QC) for LRN reagents
  • Working with federal agencies such as FBI, DHS, DoD, and EPA to coordinate response procedures

Within LPRB is the Product Development Team, which develops assays and works closely with CDC subject matter experts (SMEs) to support the LRN with research and development of new methods. The Product Development Team provides real-time PCR testing for bacterial and viral agents, and collaborates with CDC SMEs, as well as LRN labs in developing, evaluating, and validating novel rapid methods for pathogen identification.   The team facilitates the review of all assay data and documentation through the Technical Review Committee (TRC), a requirement for All LRN Assays.


SCOPE OF WORK

The Regulatory Affairs Specialist will assist LPRB with the development of quality diagnostic assays that utilize technology including, but not limited to, real-time PCR and ELISA, and their deployment to LRN member laboratories.

MAJOR DUTIES AND RESPONSIBILITIES

  • Coordinate meetings with assay development researchers and partners to discuss assay design, project progress, multi-center study plans, data analysis and review of project studies
  • Develop study plans and complete risk assessments in accordance with branch policies, and Clinical and Laboratory Standards Institute (CLSI) guidelines where applicable       
  • Prepare regulatory submissions including 510(k), Special 510(k), De Novo and EUA submissions as well as required pre-submissions, amendments or revisions
  • Prepare responses to regulatory agency questions
  • Review of device labeling to ensure compliance with regulatory requirements
  • Organize and analyze experimental data for inclusion in regulatory submissions
  • Organize and analyze experimental data and product documentation for submission to the technical review committee and for establishing substantial equivalence for medical device clearance
  • Create narratives to support labeling claims, including interpretation and organization of experimental data that support device labeling claims
  • Communicate with FDA and partners as needed to facilitate compliance
  • Document communications, issues and decisions associated with each assay and related regulatory documents

Qualifications:

MINIMUM QUALIFICATIONS

Education and Experience:

  • Degree in microbiology, biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent;

    • Bachelor’s with 7-15 years of experience in a similar role
    • Master's with 5- 10 years of experience on a similar role
    • Ph.D. with 0-5 years of experience in a similar role

Required:

  • Extensive knowledge and experience with the research activities involved with in vitro assay development, the ability to provide technical guidance to scientific personnel performing assay development research, and the ability to provide quality review of project deliverables
  • Extensive experience managing and overseeing regulatory aspects of one or more projects within a multidisciplinary scientific environment
  • Extensive experience ensuring regulatory compliance with all contract and task order requirements and quality standards
  • Extensive experience maintaining knowledge of published scientific literature and regulations related to projects being managed
  • Knowledge of biosafety requirements for research being performed
  • Strong interpersonal skills and extensive experience interacting with internal and external partners
  • Experience working with Microsoft Office, Word, Access, Excel, and PowerPoint

Desirable:

  • Demonstrated skills and experience writing project reports, research protocols and manuscripts
  • Demonstrated ability to meet or exceed project deliverables and timelines  
  • Demonstrated ability to synthesize new ideas for project research
  • Demonstrated experience using SAS, STATA, SPSS or R
  • Demonstrated experience developing real-time PCR, ELISA, or next-generation sequencing in vitro diagnostic assays

Language Skills:

  • The candidate must possess excellent oral and written communication skills in English   

REQUIREMENT:

  • Must be United States citizen or permanent resident or have authorization for employment in the United States

SALARY:  Commensurate with qualifications and experience

To apply for this position:

  • If you are viewing this position on the IHRC Career Center, please click on the "Apply Now" button.
  • If you are viewing this position on a site other than the IHRC Career Center, you may use the “click to apply” link, or you may apply by visiting our Career Center and searching for the position number listed at the top of this position description.
  • To view all of our open positions, and to apply to those positions in which you may be interested, please visit our Career Center, which can also be reached by visiting www.ihrc.com/Careers and clicking on the “View Opportunities” link.

IHRC, INC. IS AN EQUAL OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.  It is the policy of IHRC, Inc. to provide equal employment opportunities without regard to race, color, religion, citizenship, age, sex, sexual orientation, gender identity, national origin, ancestry, genetic information, veteran or disability status, or any other characteristic protected by applicable federal, state or local law, and to take affirmative action in accordance with applicable laws and Executive Orders.

 

Organization Description:

IHRC, Inc. is an international consulting and professional services corporation, and a minority woman-owned small business located in Atlanta, Georgia, USA. We assist our clients in accomplishing their missions and objectives in a timely and cost-effective manner, and we strive exceed our clients’ expectations.

Closing Date: 4/23/2019
Desired Starting Date:
Contact Name: HUMAN RESOURCES,  Regulatory Affairs Specialist
Contact Location: 2 Ravinia Dr. Suite 1200

Atlanta   GA  30346
United States
Contact Location: 2 Ravinia Dr. Suite 1200
 
  Atlanta   GA  30346
  United States
Contact Phone:  
Contact Fax:
Contact Email: resume@ihrc.com
Web Address: https://www.ihrc.com
How to Apply:

Click here

Additional Information:

Web Site Delete Date: 3/13/2019