Temp to Perm - Remote Opportunity - Regulatory Affairs Manager

Required: (Remote Opportunity - Temp to Perm) The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth. The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.

Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters

Key responsibilities

Lead Regulatory Associates or Specialists in addition to work as an individual contributor Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions) Represent RA as core team member to drive innovation on Tech.

Dev. Projects and follow through to market release. Develop Regulatory Strategies for new or modified products and prepare project plans & budgets.

Monitor and provide management with impact of changes in the Regulatory environment. Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.