Associate Principal, Regulatory Affairs

Responsible for establishing and preparing strategy for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties:

• Represent Regulatory on project teams and partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives.
• Identify regulatory requirements for the markets identified in the regulatory strategy.
• Develop and execute the regulatory strategy for the assigned market(s).
• Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
• Communicate with regulatory agencies on administrative and routine matters.
• Document, consolidate, and maintain verbal and written communication with the regulatory agencies.
• Review change order documents and assess regulatory impact of product changes on US, EU, Canada, and/or international regulatory strategy/submissions, across product lines per MicroVention procedures.
• Review promotional material and labeling for regulatory compliance as assigned.
• Develop and maintain regulatory files and records.
• Support and contribute to editing or revising regulatory Standard Operating Procedures (SOP) and Work Instructions (WI).
• Support training for global regulatory processes and system implementations.
• Build team cohesiveness by influencing and mentoring team members.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.