Hybrid Senior Regulatory Affairs Specialist

Posted last month

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About the role

  • Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers
  • Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
  • Assist in the development of regulatory strategy and updates strategy based upon regulatory changes
  • Evaluate proposed products for regulatory classification and jurisdiction
  • Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
  • Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products
  • Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
  • Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools
  • Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions
  • Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process
  • Maintain current product registrations and assist with processing registration changes when required

Requirements

  • Bachelor’s degree in an Engineering, Science, or equivalent field
  • Minimum of 3 years of experience in an FDA or highly regulated industry required
  • Minimum of 2 years in a Regulatory Affairs role required
  • Preferred RAC certification or Advanced Degree (Masters in Regulatory Affairs)
  • Previous experience with US Class II/III medical devices
  • Experience authoring regulatory submissions for product approval
  • Experience interacting with regulatory agencies

Benefits

  • Eligible for bonuses
  • Generally eligible for short-term and long-term financial incentives

Job title

Senior Regulatory Affairs Specialist

Job type

Experience level

Senior

Salary

$88,800 - $142,300 per year

Degree requirement

Bachelor's Degree

Location requirements

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