overview

Regulatory Affairs Specialist

 

Position Summary

This position is responsible for the creation, preparation and coordination of regulatory submissions and approvals in the domestic and international markets. As part of a multi-disciplinary group, this position contributes to the design, development and product launch of Corindus’ innovative robotic systems that bring improved care to patients and physicians.

Primary Responsibilities

  • Work with the Manager of Regulatory Affairs to determine effective regulatory pathways for a variety of projects and issues
  • Prepare document packages for regulatory submissions including 510(k)s, Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions, and Pre-market Approval Applications
  • Work with the Manager of Clinical Affairs to monitor clinical data, both internally and at clinical sites, as necessary
  • Under the direction of the Manager of Clinical Affairs, maintain clinical protocol revisions, clinical site documentation and assist with the management of clinical publication strategy and processes
  • Track and coordinate regulatory submission activities to ensure timeliness and commitments are met
  • Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval process
  • Review and approve Engineering Change Orders in accordance with regulatory requirements
  • Participate in new product development teams and communicate regulatory requirements for product development; facilitate internal compliance with those requirements
  • Review and approve test protocols to support regulatory submissions
  • Review device labeling and advertising material for compliance with submissions
  • Assist in regulatory compliance activities, including but not limited to Notified Body Audits, FDA Inspections, and other regulatory agency inspections and audits
  • Maintain regulatory files
  • Perform internal audits of the Quality System
  • Analyze product complaints and make recommendations regarding their reportability
  • Other duties as assigned

Desired Skills and Experience

  • Bachelor’s in Engineering or Science required. Advanced degree preferred.
  • Experience in a medical device, biotech or pharmaceutical environment preferred
  • Regulatory compliance experience in the medical device area preferred
  • Knowledge of applicable US and EU medical device regulations preferred. Knowledge of other markets is preferred.
  • Regulatory submission experience in US and EU preferred
  • Working knowledge of GMPs and GCPs preferred
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