Regulatory Affairs Manager

Join Kelly FSP as a Regulatory Affairs Manager with our Medical Device Client!

Description

• Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and supporting evidence including clinical data
• Ensure compliance with regulatory agency regulations and interpretations
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
• Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals
• Communicate, negotiate, and maintain rapport with the FDA and Notified Body reviewers to identify pre-submission requirements and ensure submission strategy alignment as needed
• Provide solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables
• Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
• Guide conformance with applicable regulations in product development, support of claims and label content
• Define data and information needed for regulatory approvals
• Collaborate in the development and approval of labeling, after evaluating conformance to regulations
• Provide Regulatory Affairs support during internal and external audits
• Plans schedules for regulatory deliverables on a project and monitors project through completion
• Assists in the development of best practices for Regulatory Affairs processes and systems
• Represents Regulatory Affairs and provide regulatory advice on cross-functional project teams
• Partners with other functions to define and obtain data to assist with regulatory submissions
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
• Review manufacturing, supplier, CIPs, labeling and risk associated changes to provide regulatory assessments for Class III US/EU products and high risk ROW
• Draft regulatory submissions and/or assessments for US/EU Class III products and submit to FDA and BSI
• Draft regulatory changes in MDRIM and manage regulatory impact ROW
• Guide/ mentor Jr. RA associates
• Partner with RA affiliates on submission pathways in their respective country
• Review marketing material as needed
• Review and assess clinical reports
• Review and approve any tender requests
• Update RA database with recent and ongoing submissions
• Create change orders and upload submissions in ADAPTIV (US, EU)
• Update the BSI tracker w upcoming submissions
• Update Smartsheet with upcoming submissions
• Attend meetings w RA team to acquire all information
• Attend meetings with project team and cross functional partners