Open Position: Manager

Function:  Quality/Regulatory Affairs

Summary

This individual will contribute their compliance (quality and regulatory) skills to the successful development of medical devices and combination products which will advance the current state of treatments. As an integral member of the QA/RA team—he/she will be fully engaged in leading teams through FDA, CE Mark, and CLIA compliance issues involved with the medical device product development cycle and its impact on the post market requirements.

Please send your resume and a cover letter to careers@edgeonemedical.com and include Quality/Regulatory Affairs Manager in the Title.

Essential Duties and Responsibilities

  • Quality Representative of the EdgeOne Quality System, with ownership, oversight, and continuous improvement of the EdgeOne’s ISO 13485 compliant QMS.
  • Management of internal and external audits, observations, responses and applicable certifications.
  • Oversight and execution of quality system and product development deliverables (i.e., Procedures, Risk Assessments, CAPAs, Complaints, protocols/reports, etc.) for client specific projects.   
  • Development of client relationships and personnel commensurate with their job responsibilities.
  • Coach, train and mentor engineering (design and support), quality, R&D, and regulatory affairs on all facets of quality and regulatory requirements and processes that impact regulatory filings, the quality system or client product.
  • Quality support for notebooks, protocols, and report deliverables created in EdgeOne’s testing lab
  • Monitor the implementation and effectiveness of the EdgeOne Quality system, and when applicable client processes.
  • Review 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.
  • Partner with sub-suppliers in providing necessary services to the client.
    Responsible for administering training and workshops.
  • Perform other duties as assigned

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.

  • Thorough understanding and experience with ISO 14971:2007, 13485:2003, and 21 CFR 820.
  • Thorough understanding and experience with medical device Design Controls.
  • Experience and understanding of Medical Device Directive 93/42/EC. 
  • Experience and familiarity with US and European regulatory filings (clinical as well as market applications).  Other country or regional regulatory experience and familiarity is beneficial (i.e. MHLW, TGA and HC).
  • Broad knowledge of the Product Development Processes and its supporting quality systems (Design Control, Product Feedback, CAPA, Supplier Quality, Change Control, Document Control, Management Controls).
  • Strong leadership, facilitation, mentoring, and communication skills.
  • Strong multi-tasking and project management skills.
  • Must be able to interact and communicate with all levels of the organization.
  • Must be able to interface with clients on a personal level.
  • Motivation and desire to share your knowledge with the broader MedTech community.

Experience and/or Education

Minimum Requirements:

  • Bachelor’s degree in Engineering, Life Science, or Equivalent.
  • 5-8 years product development and quality systems experience a must.
  • Experience in Design and Development of medical devices
  • Experience managing a Quality System
  • Experience with Regulatory Submissions and agency interactions
  • Experience with regulatory/compliance principles for medical devices
  • Expertise in application of ISO 14971 and Design Control

Desired Requirements:

  • Experience with regulatory/compliance (cGMP) principles for combination products
  • Experience with IDE’s, PMA, 510k, CE Mark Technical Files and Design Dossiers
  • Expertise in software development and creation of SW design deliverables
  • Experience with in-vitro diagnostic device product development
  • Experience with CLIA certification process
  • Experience creating/establishing a quality system

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.