Internships

Atossa Genetics is a women’s healthcare company specializing in the development of proprietary medical devices and laboratory services to stratify, assess, profile, and monitor the breast health in patients.

We accept enthusiastic, high quality undergraduate or graduate students interested in learning the industry as interns. Stipend may be awarded depending on the skills and experiences. Please send your resume and contact information for two references to internship@atossagenetics.com.

Current Opportunities

Sales Account Specialist, Laboratory Servicess-Los Angeles, Dallas/Houston, Atlanta

This position will work with the National Sales Director to increase sales revenue by promoting lab tests to a physician customer base.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Market the Company’s pharmacogenomic and women’s health laboratory services to general practitioners (MD, DO, ND), physicians, family practice, OB/GYN and breast centers within the geographic marketplace of assigned area
  • Meet with a minimum of 35 health care professionals weekly marketing laboratory pharmacogenomics services
  • Complete monthly reports with format to be determined by manager
  • Participate in weekly meetings discussing strategies, success, and challenges
  • Train, with Medical Director oversight, clinicians on sample collection guidelines
  • Ensure proper documentation completed when setting up new customer accounts
  • Provide weekly and monthly forecasts Write annual business plan, quarterly execution plan
  • Work with assigned Clinical Liaison in territory as needed
  • Input customer meeting notes into company CRM system (SalesForce)
  • Prospect leads to expand sales using purchased database
  • Build relationships and identify the prospect’s need for our products and services
  • Develop and utilize presentation skills to successfully position our products
  • Provide customer with product literature and have the ability to discuss the points that are most relevant to customer’s situation
  • Follow Company HIPAA, Sales and Marketing, and other compliance guidelines
  • On-time compliance for all reporting requests

Education, Experience and/or Skills Required

  • Bachelor’s degree required
  • Minimum 5 years’ experience in medical device or pharmaceutical sales
  • Current sales contacts in women’s health desired
  • Solid sales presentation and communication skills, both verbal and written
  • Proven track record of success in meeting assigned sales quotas
  • Strong relationship management skills
  • Ability to self-manage
  • Excellent customer service skills

To apply for this position please send your resume to hr@atossagenetics.com.

VP, Global Quality Assurance & Regulatory Affairs

The Vice President of Global Quality Assurance and Regulatory Affairs (VP QA/RA) will lead and manage the Regulatory, Quality Control and Quality Assurance functions for the organization. The position includes responsibility for the refinement of regulatory strategy working in collaboration with the CEO and other senior management, for implementation insuring compliance with pertinent regulations, standards and clinical practice guidelines. This role is responsible for the Quality and Regulatory Compliance of products and services developed, produced, tested, and released for pre-clinical and clinical trials and, ultimately, for commercial use. This role is also responsible for driving the quality and regulatory activities for the Quality Management System (QMS) implementation across the Organization and ensuring contract manufacturer(s) are in compliance.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Design and implement the interface with regulatory authorities. Function as the Regulatory Affairs representative on project teams; and will manage the Regulatory Affairs coordination with partner companies and vendors.
  • Lead responsibility for the content, production, assembly and administration of worldwide regulatory submissions, overseeing all aspects of ongoing and new regulatory submissions, U.S. and International 510(k), TPG licensing, CE marking.
  • Foster a culture of excellence, professional integrity, and respect for patient safety and will insure that all necessary management systems are in place to make these high principles actionable and assure the compliant practices that will result in the Company’s ultimate medical and commercial success.
  • Provide strategic direction and guidance to Executive Management regarding quality & regulatory timelines for new and revised products and/or processes, and/or regulations & guidance’s.
  • Establish, maintain and monitor ongoing Company-wide quality and compliance policies with applicable regulatory agencies, and other international quality compliance requirement for other countries including reporting, records, training, systems and processes that ensure the Company’s quality system is functioning properly.

Education, Experience and/or Skills Required

  • Bachelor’s degree in in a relevant area of science or medicine, and additional credentialing in management or the regulatory affairs profession which provides the professional insight and credibility necessary to successfully lead the function. An advanced degree is preferred.
  • Fifteen years’ experience in Quality Assurance and Regulatory Affairs in roles of increased responsibility with at least three to five (3-5) years’ experience at the VP level or above.
  • Direct experience with drug regulatory submissions and product approvals worldwide including a track record of effective collaboration with regulatory agencies globally.
  • Experience preparing FDA 510k and CE mark submissions and documentation and international device license and registration.
  • An overall understanding of Quality requirements with respect to FDAs Quality System Regulation, ISO-13485—2003, as well as Global medical device regulations and directives.
  • Demonstrated expertise in the management of a pharmaceutical industry regularity affairs function, including building and leading regulatory affairs, QC and QA teams.
  • Travel up to 30% to domestic and international operations & suppliers.

To apply for this position please send your resume to hr@atossagenetics.com.