Open Positions

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

• Represent Regulatory on project teams and partner with project team to ensure alignment of global regulatory strategy with the team objectives.
• Identify regulatory requirements for the markets identified and work independently in developing global regulatory strategy for assigned projects and develop approaches to solutions.
• Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects and processes that span outside of immediate job area.
• 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 ascertain impact on current regulatory approvals.
• Review promotional material and labeling for regulatory compliance.
• Develop and maintain regulatory files and records.
• Support and contribute into developing, editing, or revising regulatory processes.
• Lead 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.