Principal, Regulatory Affairs

Responsible for preparing strategy for worldwide product approval submission activities, focusing on submission activities in the US, EU, and Canada, and ensuring compliance with FDA and international regulatory agency requirements for Neurovascular and Peripheral devices.Job duties:Represent Regulatory on project teams and partner with project teams to ensure alignment of global regulatory strategy with team objectives.Identify regulatory requirements for the identified markets 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 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 to 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, and demonstrate ethics and integrity in all matters and at all levels throughout the organization.Perform additional duties as assigned.Job ID: 12258BRSalary Range: $106,712 - $144,282 (Compensation could be higher based on education, experience, and skillsets).Minimum Requirements:Bachelor’s degree in a scientific or technical discipline or relevant field of study.Minimum seven (7) to ten (10) years of professional regulatory experience.Strong technical writing skills as evidenced by multiple successful US FDA Class II/III electro-mechanical medical device submissions, EU CE Mark applications, Health Canada submissions, including clinical investigation submissions (e.g., IDE).Prior direct involvement interfacing with regulatory authorities through oral and written communications regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.Detail-oriented.Strong written and verbal communication skills.Proficient computer skills, including MS Word, Excel, PowerPoint, Outlook, and Teams.Preferred Qualifications:Advanced degree in a scientific or technical discipline or relevant field of study.Direct experience with product development of active implantable devices with software and/or electrical/electromechanical testing (IEC60601 standard series), software validation (ISO62304).Experience in leading large-sized project teams across multiple product lines.Ability to work well in a team environment.Proven technical abilities; analytical and organizational skills.Ability to comprehend technical documents and concepts.

#J-18808-Ljbffr