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Regulatory Affairs Associate/Manager/Director (Hiring all Levels) at

Regulatory Affairs Associate/Manager/Director (Hiring all Levels)

Work From Home, GA Contractor
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  • Looking for Regulatory Affairs Professional with all amounts of experience. Manager is looking for entry and sr level people with experience in the medical device industry.
  • Should be able to write submission, review changes, the device we’re bringing to market is a Class III (Transcatheter, mitral valve replacement – really early in the process) so great opportunity to get in, huge room for growth etc.
  • Representing Regulatory Affairs with Cross functional team – should have experience having gone through submission process, will review docs going to FDA, notified bodies… and responsible for submitting, reviewing design & regulatory changes, and impact assessment.
  • Preferred experience in CE MDD Technical File experience or submission experience, US submission experience, and International submission experience.
  • Prior experience authoring MDD Technical Files, US/CE submissions, and/or addressing regulatory agency questions is a plus.
  • Prefer (not required) experience in EU MDR submission activities, including representing RA in project meetings, STED compilation, publishing/submission to regulatory body, corresponding with regulatory agency to address questions.

  • Ensure global regulatory compliance (FDA, MDD, CMDR)
  • Address regulatory compliance and other regulatory policy issues
  • Lead worldwide regulatory affairs and develop regulatory strategy, implement strategy and manage efforts of regulatory staff
  • Ensure a global regulatory strategy
  • Identify and implement process improvements for regulatory affairs
  • Build a regulatory affairs department to support current and future clients in regulatory oversight and support regulatory filings
  • Manage timelines for regulatory submissions
  • Assist Denmark, German regulatory affairs
  • Develop and oversee the strategic plan for regulatory affairs
  • Establish national regulatory affairs and market development strategy and plan
  • Develop global regulatory strategies and update based upon regulatory changes
  • Provide strategic state government affairs guidance
  • Direct and prepare regulatory submissions
  • Facilitate meetings with regulatory agencies
  • Support regulatory product submissions or registrations
  • Provide support for international registrations and support to global regulatory affairs teams
  • Facilitating compliance with all regulatory requirements, including interface with regulatory agencies
  • Manage all regulatory projects, developing and executing regulatory plans
  • Direct the reimbursement and regulatory affairs of client facilities
  • Manage the regulatory group that perform regulatory and quality compliance functions

Recommended Skills

  • Impact Assessment
  • Regulatory Filings
  • Regulatory Requirements
  • Market Development
  • Strategic Thinking
  • Regulatory Compliance
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