At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.
Sr. Regulatory Affairs Analyst
Pleasanton, CaliforniaReq ID 2211971Category Regulatory AffairsDivision Allergan Aesthetics
The Senior Regulatory Affairs Analyst is responsible for successfully delivering project management capabilities for cross-functional teams within the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. Responsibilities include developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and supporting process improvement efforts to help achieve business performance goals for regulatory compliance and productivity.
Assist in the development and deployment of the regulatory program that ensures aggressive product approval, adoption within the international standard ISO13485; 21 CFR 803, 806, and 820; Medical Device Regulations 2017/745/EU; MDR Annex XVI Common Specifications and other applicable regulations and guidelines in accordance with corporate objectives.
Partners with various teams throughout organization (Marketing, Promotions, Operations, R&D, Quality, etc.) on regulatory issues and/or strategy. Effectively guides, communicates and implements determined strategy with the appropriate teams.
Assists with the regulatory submission documents for new products or changes to existing health authorities' filings, including domestic and international submissions and registration.
Writes, submits, and coordinates new product notifications, 510(k)s, Letter to Files, CE Mark Technical Files/Dossiers and international regulatory submissions in various countries.
Assists with the management and execution process for international registrations including providing guidance with localization and labeling requirements.
Evaluate proposed engineering, manufacturing, labeling and quality system changes and perform regulatory impact assessment for regulatory filings and approvals
Support adverse event reporting, field actions, change requests, lifecycle management, audits and interactions with regulatory agencies/notified bodies.
Oversee processes involved with maintaining annual licenses; registrations, export certificates and device listing information
Develop, implement and manage appropriate regulatory SOPs and Work Instructions
Review and approve advertising and promotional items to ensure regulatory compliance
Perform regulatory intelligence, assist in gap assessments and notify the organization of changes in US, EU and Rest of World laws, regulations, directives, guidances, standards, etc. that impact ZELTIQ products.
Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, EU Medical Device Regulation (MDR), and all other international regulatory requirements with which ZELTIQ complies.
Perform other related duties as assigned.
Bachelor’s or advanced degree in in a scientific field is required
Minimum of 2 years of experience in regulatory affairs.
Ability to be a team player and a partner to the cross-functions teams; be part of the solution and demonstrate ability to use risk-based judgment.
Ability to read, analyze, and interpret engineering documents, standard operating procedures, standards, guidance documents and regulations.
Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a job and to assign other duties as necessary and at any time.