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

SENIOR ACCOUNTANT – REVENUE

The Senior Accountant will support the Corporate Controller by assuming a wide range of accounting and financial reporting-related responsibilities for a fast growing, biotech/life science small public company.​  Responsibilities include month end close, general ledger reconciliations, SEC reporting and compliance, internal & external audit compliance, analysis and reporting of revenue and related costs as well as interaction cross functional teams. To be successful in this role, you must have strong knowledge of revenue recognition and the ability to interpret complex revenue arrangements.

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

  • Perform month-end revenue closing activities and account reconciliations, record revenue related journal entries
  • Assist with in timely and accurate filings of SEC reporting and compliance, including 10Qs and 10ks
  • Work closely with the third party billing company to ensure timely recognition and collection of revenue
  • Assist/lead various automation projects, including ERP, billing systems, expense automation tools
  • Perform technical research and interpretations to ensure proper revenue recognition in accordance with company policy and revenue recognition accounting standards
  • Participate in revenue analytics to provide monthly financial reporting data for Controller
  • Assist with the review of contracts and related documents to identify appropriate billing and revenue recognition issues
  • Assist as needed in the AR close process
  • Support audit activities and be main point of contact for all revenue cycle testing and explanations
  • Various other ad hoc analyses as required

Education, Experience and/or Skills Required

  • Bachelor’s degree in Accounting
  • 3-5 years of experience in public companies; healthcare/biotech industry experience preferred.
  • In-depth knowledge of accounting principles, internal controls and processes
  • Strong revenue recognition experience with an analytical approach to data modeling and forecasting
  • Understand customer invoicing/contracts, implement invoicing best practices
  • Excellent attention to detail and accuracy, be organized, and have excellent written and verbal communication skills
  • Proficient in accounting applications and systems
  • Should be a hands-on, energetic self-starter with strong problem-solving skills

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

 

SENIOR MANAGER, DEVICE QUALITY ASSURANCE AND REGULATORY AFFAIRS

The Senior Manager, Device QA/RA is accountable for the effective management of all regulatory activities associated with the development, registration and maintenance of assigned Atossa Genetics medical devices worldwide.  This position manages the process of fulfilling regulatory requirements associated with the product quality (e.g., 21 CFR 820 QSR) and marketing approval of new products and continued support of marketed products.  The Senior Manager works independently with consultation by Regulatory Management on regulatory and quality strategy for research, transition and development projects in order to shorten time to FDA approval and obtain the most favorable outcome, and provides timely updates on all projects to Senior Vice President, Global RA/QA.  The Senior Manager works on complex regulatory and quality issues in which analysis requires an in-depth evaluation of various factors, and regularly interacts with internal cross-functional teams as well as CROs and CMOs to provide guidance and solutions for difficult regulatory and quality situations and issues.

In addition, the Senior Manager is responsible for the regulatory submission and the review and implementation of departmental systems for regulatory submissions and safety reporting.  The Senior Manager may be supported by Senior Vice President, Global RA/QA, who assists in designing standard requirements for submissions (e.g. 510 (k), PMA, CE mark, etc.) and preparation of relevant procedures describing responsibilities and processes for the regulatory affairs department.

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

  • Provides recommendations to Project Team or ad hoc committees with consultation by Senior Vice President, Global RA/QA on regulatory and quality direction for development projects and approved products to be incorporated into the development strategy.  Recommendations are based on knowledge gained from direct FDA experience, previous submissions and FDA Advisory Committee meetings.
  • Provides regulatory and quality advice and consultation for products within their responsibility to Senior Management for incorporation into the decision making process.
  • Establishes and maintains regular and effective interface with FDA officials to acquire a knowledge base of regulatory and quality requirements and strategy to enable Atossa Genetics to efficiently and effectively shorten development and FDA approval times.
  • Prepares submissions of registration documents (510 (k), PMA, CE mark, etc.) with consultation by Regulatory Management.
  • Reviews material for completeness, internal consistency with other documents, conformance to FDA regulations; assures readiness for submission by gathering missing information, resolving internal consistency and regulatory issues; compiles high quality submissions that are fileable and meet all FDA requirements.
  • Writes meeting minutes of meetings/teleconferences with FDA are clearly understood and agreed upon by all participants and communicated to appropriate individuals within one week.
  • Assures that all interactions (verbal or written) with regulatory authorities reflect credible regulatory and corporate reputation.
  • Develops a reporting system for presenting Management review quality metrics reports to Senior Management.
  • Develops Quality systems standard operating procedures and maintains the current Quality systems SOPs
  • Works with CMOs to monitor projects in terms of quality metrics system with tracking and trending.
  • Provides hands on support for the Design Control system, Device Master File, Device History File and provides direction to other departments.
  • Assists with the material and lot disposition for material with non-conformances.
  • Revises, develops and maintains Quality Systems standard operating procedures (SOPs) for Device Changes, Deviations, Quarterly and annual product reporting.
  • Assists in the training programs for effective Quality systems SOPs to employees.
  • Works with the Senior Vice President, Global RA and QA to develop standardized procedures for the preparation of regulatory submissions to assure consistency within and between various Centers at FDA and other regulatory agencies.
  • Collaborates with Regulatory Operations staff to assure timely completion of paper and electronic submissions for the Regulatory Affairs department.
  • Prioritizes assignments to meet corporate timelines.
  • At the request of Business Development, reviews and provides evaluation of the regulatory implications of licensing and acquisition candidates to make appropriate business decisions.
  • Identifies and clearly communicates all regulatory issues related to projects to Regulatory Management.
  • Assists Senior Vice President, Global RA and QA with department budget.
  • Maintains strong cross-functional communications with internal cross-functional teams and CMOs. This requires providing regular QA update reports, timely communications regarding resource concerns, and prompt notice of QA issues that impact the regulatory compliance as a whole.
  • Collaborates effectively with members of the various project teams and other employee groups.

Education, Experience and/or Skills Required

  • BS degree in Science or Engineering or equivalent.  Advanced degree a plus.
  • 10+ years’ experience in the medical device/biopharmaceutical industry.
  • 7+ years’ experience in Regulatory Affairs.
  • Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
  • Ability to communicate effectively orally and in writing to maintain effective links with QA management, contract manufacturers, contract employees and project team members.
  • Strong interpersonal and communications skills, collaboration/teamwork, and adaptive skills required.
  • Highly organized.
  • Capable of supporting numerous projects simultaneously.
  • Able to travel approximately 20%.

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

 

SENIOR QUALITY/REGULATORY AFFAIRS TECHNICIAN

Under the direction of the Senior Manager, Quality Assurance/Regulatory Affairs, the Senior Quality/Regulatory Technician provides Quality System and Regulatory Affairs support and guidance to the Operations, Engineering, QA/RA, Clinical and Sales teams.

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

  • Provides Quality & Regulatory oversight/guidance for company product lines and quality systems.
  • Able to combine input from multiple sources to provide solutions to teams, manufacturing, and contract manufacturing sites regarding product quality, design, and regulatory compliance.
  • Reviews and approves work for inclusion in complaints, Medical Device Reports (MDRs), adverse events and audits and assists in the management of actions and tasks which support these activities.
  • Assists and participates in corrective and preventive actions (CAPA)-related activities.
  • Assists and handles document control activities.
  • Communicates issues or developments identified during quality assurance activities and provides recommended improvements to responsible functional areas.
  • Assists in the ECO/DCO process, Label Reviews and provides guidance to product development teams throughout the product development process (PDP) to ensure compliance to the required PDP deliverables, resulting in the development of safe and effective medical devices.
  • Periodically reviews the suitability and effectiveness of the quality system with management. Analyzes data from various sources (including, but not limited to: Non-Conformances, Complaints, etc.) to drive decision-making and effective corrective/preventive actions.
  • Assists in maintaining documentation associated from nonconformance’s, complaints, audits etc. to ensure documents for the QMS are properly maintained
  • Recommends, leads, and/or supports projects for improvements to the Quality System.
  • Assists functional groups during FDA Inspections, ISO audits etc. to provide objective evidence required during those activities
  • Ability to communicate and/or liaison effectively with various regulatory bodies (FDA, ISO, NRTL etc.)

Education, Experience and/or Skills Required

  • AAS in engineering/business related area or equivalent experience in a medical device environment.
  • 5 or more years of relevant medical device industry experience with Class I, II, and III devices
  • Comprehensive knowledge of Quality concepts, regulatory compliance requirements and tools including ISO 13485:2003, FDA QSRs, Medical Device Directives, Canadian Medical Device Regulations, etc.
  • Completely proficient in product & process development concepts, including change control and risk management.
  • Applies organizational and technical knowledge to move teams through issues.
  • Problem solving abilities applying statistical techniques to address issues and investigations.
  • Excellent written and verbal communication skills including ability to communicate technical information. Must be fluent in English
  • ASQ Certification or similar preferred.
  • Knowledgeable of MS Office to include PowerPoint & Excel – knowledgeable of creating charts, graphs and statistical analyses.

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

 

If you are interested in employment at Atossa Genetics:

Please send your resume and the contact information of two references to hr@atossagenetics.com or send an email for more information.