As an individual contributor, the function of the Regulatory Affairs Specialist is to support the Regulatory Affairs Department ensuring compliance with company standards and the applicable US and international medical device/drug regulations in which the company does business. The individual will prepare product submission documentation, evaluate design/manufacturing changes for effects on regulatory filings, and provide guidance to project teams as it relates to application of regulatory requirements. The individual will execute tasks and play a consultative role by partnering across internal business functions. The individual may also have/lead discussions with Regulatory Bodies.
Roles And Responsibilities
SOP development and review
Lead development of regional regulatory strategy and update strategy based upon regulatory changes with limited supervision
Determine and communicate submission and approval requirements
May participate in risk-benefit analysis for regulatory compliance
Understand business environment
Self-motivated and willingness to learn and proactively problem solve
Ability to work an 8 hour day
Understanding compliance to Corporate and Regulatory procedures/ requirements and goals
New product registrations, assessing changes to existing registrations, and maintaining registrations current for assigned products/geographies
Demonstrate a strong degree of knowledge in excel spreadsheet maintenance, use of outlook tools, sharepoint, SAP based systems, and other computer programs used for tracking and reference.
Maintain records and documents for established systems that support regulatory activities and requirements.
Strong attention to detail, highly organized, and able to manage multiple projects simultaneously.
Lead projects/initiatives.
Develop and remain current on applicable internal procedures/process(s) and applicable regulations (US and INTL).
Required Qualifications
EDUCATION: A Bachelor´s degree in a relevant disc
📌 Especialista Regulatorio (México)
🏢 Avanos Medical
📍 México
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