As an innovative and growing company, Epsilon Imaging strives to deliver cardiovascular visualization, analysis and management solutions that exceed customer expectations for an improved patient continuum of care. We are seeking team members willing to work in a fast paced environment with challenging opportunities focused on customer satisfaction, please send a resume along with a cover letter to careers@epsilon-imaging.com

Current career opportunities include:

Quality & Regulatory Manager

FSLA STATUS: Exempt

BASIC FUNCTION: Quality System Operations & Regulatory Affairs

REPORTING TO: CEO

REQUIRED TRAVEL: <10%

PRIMARY DUTIES:

Quality System Operations:

  • Perform all periodic tasks and analyses required by Epsilon’s QMS of the Quality Mgr
  • Perform/manage the Document Control process
  • Identify Personnel Training needs, initiate/provide training, document training
  • Perform/manage the Complaint Handling process
  • Identify/initiate CAPAs, monitor open CAPA plans and drive to resolution
  • Maintain Device History Records; ensure DHRs are properly initialized
  • Coordinate Management Review process; lead and present the reviews
  • Perform/manage Quality Data Analyses
  • Initiate and respond as needed to Internal Audit processes
  • Develop Quality Plans and provide periodic status against plans
  • Perform/manage Purchasing Controls process
  • Oversee and participate in Design Control and change management processes
  • Ensure all Epsilon QMS processes are being complied with by all personnel
  • Maintain and enhance Epsilon QMS processes and documentation

Regulatory Affairs:

  • Monitor Complaint Handling process for issues requiring regulatory action
  • Review engineering change requests and identify applicable regulatory requirements
  • Ensure Technical File is maintained current
  • Participate in risk analyses and Risk Management process
  • Review and ensure QMS process changes and additions conform to regulatory needs
  • Monitor for applicable regulatory changes; obtain and review new/revised directives/standards/guidance; adjust Epsilon systems as required
  • Submit all required periodic and any other required reports to regulatory entities
  • Investigate regulatory regimes of other countries as needed
  • Plan and prepare/assemble and track regulatory submittals when and where needed
  • Evaluate, engage, and oversee regulatory consultants/contractors for Epsilon
  • Maintain Epsilon regulatory registrations
  • Point-of-contact for regulatory visits by the FDA inspectors and Notified Body auditors

MINIMUM QUALIFICATIONS

  • 5+ years of experience in the medical device industry primarily in a quality and/or regulatory role
  • Working knowledge of current FDA QSR, ISO 13485, MDD 93/42/EEC, CMDR
  • Ability to assess current company practices against external standards, guidance, regulations, and industry ‘best practices’ and judge applicability to Epsilon products
  • Ability to make decisions related to product quality, acceptance criteria, marketing materials, and release of company products that will withstand regulatory scrutiny
  • Ability to identify and implement improvements to quality system processes
  • Ability to find optimal process solutions that satisfy regulatory requirements and maintain and enhance Epsilon’s operational agility as well as its product and service quality
  • Effective written and oral communication skills
  • Effective reasoning and problem solving ability
  • High level of attention to detail
  • Organizational and motivational skills to exert the necessary influence over highly entrepreneurial and innovative engineering, fulfillment and support operations
  • BS in Engineering or Life Sciences

HIGHLY DESIRABLE

  • 10+ years of experience in the medical device industry primarily in a lead quality and/or regulatory role
  • Coursework/training in quality system management and applicable experience in organizing, administering and auditing quality management systems
  • Coursework/training in regulatory affairs and applicable experience in engagements with regulatory authorities and regulatory affairs services providers
  • Track record of responsibility for successful FDA and/or Notified Body inspections/audits
  • Master’s degree in Quality or Business-related field of study