Principal, Regulatory Affairs

Overview

Join to apply for the Principal, Regulatory Affairs role at Terumo Neuro

Posting country: US - United States

Responsible for establishing, preparing, and leading the strategy for worldwide product approval submission activities. As a recognized expert, manage multiple large projects or processes. 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.

• 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 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 Micro Vention 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.

• 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.
• Ability to come into the office a minimum 3 days a week
• Strong technical writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions, and/or rest of the world (ROW) registrations across product lines.
• Prior direct involvement interfacing with regulatory authorities through oral and written communications regarding pre-submissions 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.

• Advanced degree in a scientific or technical discipline or relevant field of study.
• Experience in leading large sized project teams across multiple product lines.
• Ability to work well in a team environment.
• Proven technical abilities; analytical and organization skills.
• Ability to comprehend technical documents and concepts.

• Associate

• Full-time

• Legal

• Medical Equipment Manufacturing