Position: Senior Manager, Regulatory & Quality

Location: Gaithersburg, MD

Position Description:

The Senior Manager, Regulatory and Quality is a core member of the DxNow, Inc. team directly responsible for the development and submission of the Company’s FDA, CE, and other regulatory filings, as well as our Quality Management Systems in accordance with ISO 13485, FDA Quality System Regulation (QSR), Medical Devices Directive (MDD, CE Marking), and the Canadian Medical Devices Regulations (CMDR). This is a hands-on position requiring intimate involvement with all aspects of medical device regulatory and quality systems implementation and this individual will function as the Company’s Quality Management Representative (QMR).

Responsibilities:

  • Prepare and submit regulatory applications such as FDA 510K, CE, etc.
  • Review device labeling and promotional materials to ensure compliance with US and international regulations.
  • Act as a core member of the Company’s development and manufacturing teams, providing regulatory feedback and guidance.
  • Perform internal and external audits to assure compliance with Company policy as well as agency requirements and regulations.
  • Review product and/or manufacturing changes for compliance with DxNow and external applicable policies and/or regulations.
  • Establish, track and manage regulatory project timelines.
  • Maintain well organized, auditable regulatory files.
  • Manage quality-related activities with outside vendors.
  • Provide quality training to staff.
  • Manage and oversee the implementation of a quality management system for DxNow’s medical devices that meets the requirements of regulatory bodies in the United States, Europe, Canada, and other key markets.
  • Ongoing maintenance of the QMS post-registration to include continual improvement and monitoring.
  • Other duties as required.

Qualifications:

  • Minimum of 5 years hands-on development, submission and implementation of regulatory filings and quality systems in a life sciences environment, specifically 510(k) Class II medical devices.
  • Demonstrated past successful development and implementation of quality management systems, as well as familiarity with CE, ISO and FDA 510(k).
  • Minimum of Bachelor’s degree in the life sciences or engineering. Advanced degree preferred.

Success Profile:

  • Hands-on, action oriented.
  • High energy.
  • Self-starter able to work autonomously and within a cost-constrained environment.
  • Copes well with change and ambiguity.

About DxNow

DxNow (www.dxnow.com) is combining novel, portable bio-imaging systems with microfluidic-based consumables for life science applications leveraging exclusively licensed technologies developed in the Demirci Bio-Acoustic MEMS in Medicine Labs at Harvard Medical School-Brigham & Women’s Hospital and Stanford Medicine.

Founded in 2013, DxNow is a privately-held Delaware C corporation whose corporate headquarters and primary research and development labs are in Gaithersburg, Montgomery County, Maryland, USA. This location offers proximity to the FDA, U.S. Patent & Trademark Office, National Institutes of Health and other agencies relevant to DxNow’s business interests, as well three major airports.

Dynamic, Highly-Experienced Team

  • Current team combines 200+ years of industry experience
  • Team-building emphasizes highly-qualified, proven contributors able to thrive in a dynamic and rapidly-evolving environment

Innovative Products

  • Current and near-term products address $2B+ market opportunity in fertility and forensics
  • Total addressable market for current + pipeline products >$31B

Disruptive Technologies

  • Enable detection, sorting and selection of wide range of targets (sperm, blood cells, bacteria, viruses) Eliminate need for sample preparation when working with unprocessed whole blood, saliva, semen, serum and urine.