Senior Regulatory Affairs Specialist (Hybrid)

What you will do

• 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.

What you need

• Bachelor's degree required. Preferred to be in Engineering, Science, Regulatory Affairs, or a related technical field.
• Minimum of 2 years in a Regulatory Affairs role required.
• Experience in an FDA or highly regulated industry required.

Preferred

• Experience supporting Software as a Medical Device (SaMD) products or software-enabled technologies within a regulated industry.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs).
• Previous experience with Class II/III medical devices.
• Experience authoring regulatory submissions for product approval.
• Experience interacting with regulatory agencies.