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
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