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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research
Industries
Medical Equipment Manufacturing
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