Director, Quality Assurance & Regulatory Affairs

Organization
ASELL, LLC
Job Location
11438 Cronridge Drive
Suite X
Owings Mills, MD 21117
Benefits

ASELL offers competive benefits, including health care insurance, 401(k) with company matching, life insurance, and paid time off.  

Job Description
  • Job duties:
    • Lead all Quality Assurance (QA) and Regulatory Affairs (RA) activities in support of the development of an in vitro diagnostic device (IVDD)
    • Lead the implementation of a Quality Management Systems (QMS) that complies with the FDA’s quality system regulations (e.g., 21 CFR 820) and ISO 13485.
    • Ensure compliance with the FDA QSR and ISO 13485 during development, validation, production and sustainment efforts
    • Lead team with focus on FDA regulation compliance and successful FDA device clearance
    • Lead regulatory affairs activities that lead to a device clearance or approval from the FDA
    • Lead regulatory affairs activities that lead to a device clearance or approval from foreign regulatory authorities (e.g., CE mark)
Requirements
  • Required Skills:
    • RA/QA experience with FDA-cleared or approved products
    • Knowledge of scientific, regulatory, clinical, quality and process development aspects of IVD product development
    • Experience in quality control and documentation of design and results in a FDA regulated environment
    • Strong aptitude with Microsoft Office products, such as Word, Excel, and PowerPoint.
  • Recommended Skills:
    • Experience with reagent and assay development
    • Experience overseeing and auditing RA/QA activities at external suppliers or development firms
  • Qualifications:
    • Bachelor’s degree in related field
    • 5+ years RA/QA experience in IVD industry while working on an FDA cleared or approved device
  • Additional Requirements:
    • Ability to interact with colleagues in a team environment
    • Must have experience in managing and collaborating with diverse organizational elements / groups and resolving conflicts within teams
    • Must have excellent organizational, record keeping and communication skills (oral and written), with excellent presentation technique
    • Must have a strong work ethic to generate high quality work under tight deadlines
    • A proactive attitude
    • Must have demonstrated leadership and self-motivation.  Possesses the ability to motivate and guide others to meet objectives
    • Must have demonstrable project management and creative problem solving skills.
How to Apply

Please send your resume or CV to careers@asell-llc.com

About Our Organization

ASELL is a medical device developer that is working with government and commercial partners to turn science into solutions.  ASELL is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, or national origin.

www.asell-llc.com

Nature News reports that doing a postdoc might not help researchers find employment.

Pennsylvania State University's Kathleen Grogan says researchers need to approach data on gender and racial diversity in the sciences like they would any other dataset.

The National Science Foundation is adding questions about sexual orientation and gender identity to its Survey of Earned Doctorates, according to Science Careers.

Nature asked scientists whether they were satisfied with their careers to find that most were, with some variation.