Open Position: Associate, RA/QA

Function:  Regulatory Affairs/Quality Assurance (RA/QA)

Summary

Contributes their technical and compliance (quality and regulatory) skills to the successful development of medical devices and combination products as well as to the Quality System elements required to support the development and maintenance of such products. An integral member of the QA/RA team—will be interacting with teams involved with FDA, CE Mark, and CLIA compliance issues involved with product development cycle and its impact on the post market requirements.

Please send your resume and a cover letter to [email protected] and include Associate, RA/QA in the Title.

Essential Duties and Responsibilities

  • Supports the Quality (Management) Representative of the EdgeOne Quality System with maintenance and continuous improvement of the EdgeOne’s ISO 13485 compliant QMS
  • Supports the development and remediation of client Quality Systems
  • Supports in internal and external audits, observations, responses and applicable certifications.
  • Contributes to quality system and product development deliverables (i.e., Procedures, Risk Assessments, CAPAs, Complaints, protocols/reports, etc.) for client specific projects
  • Supports the development of regulatory strategies, submissions and pre-submission meeting requests with agency
  • Supports Quality review of laboratory documentation, including testing protocols and reports
  • Assists in the review of data feeders including but not limited to internal and external audit observations, CAPA’s, process behavior trends, customer feedback, and management review to determine effectiveness of the quality system

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Bachelor’s degree in Engineering, Life Science, or Equivalent
  • 2 -3 years experience in quality systems and/or regulatory affairs
  • Familiarity with ISO 14971:2007, 13485:2016, and 21CFR820
  • Familiarity with US and European regulatory filings.
  • Strong multi-tasking and communication skills
  • Must be able to interact and communicate with all levels of an organization
  • Motivation and desire to share your knowledge with the broader industry community
Equal Employment Opportunity

Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.