Paulina Stopka

Experience

• 

  McCormick & Company

  Jan 2018 - Jan 2022

  • Responsible for the management of regulatory compliance, regulatory/quality informatio.• Provides consultation in effort to complete regulatory information in support of commercialization and related processes.• Respond to food legislation queries from internal customers. Approves product formulations, copy documents, raw materials and artwork to ensure compliance with legislative requirements.• Interprets evaluates and applies regulations, industry standards and customer requirements to proposed and existing products.• Support Central Technical functions and NPD – to ensure understanding and compliance with legislative requirements.• Leads projects, develops internal procedures, identifies process improvements and participates in cross functional projects. • Leads with departmental, cross-functional, or customer training and shares information with internal staff and customers. Meno dettagli Main ResponsibilitiesCollects, maintains and processes raw material technical data and associated systems, e.g. SAP, DevEX, Corporate Specifications, and launches the RMNs associated with raw material creation/change.Proactively and reactively obtains raw material information from suppliers to meet technical needs as required, in collaboration with Procurement and R&D.Populates data in a timely manner to ensure continuous production and that business needs are met.Manage the dispatch and return of specifications to and from suppliers, to ensure contractual data is in place within agreed time frames.Provides an administrative support to category quality specialists on vendor schedule (supplier approval status).Manages the requests for new raw material approvals from R&D and, where applicable, from Procurement.Acts as first point of contact for queries on behalf of category quality specialists; responsible for ensuring that data is processed in a timely manner and that effective communication is maintained with approvers, R&D and, where necessary, the Vendor to ensure that the required data is collected and processed. Meno dettagli

  • Regulatory Compliance Analyst

    Jan 2020 - Jan 2022

  • Specification and Certification Analyst

    Jan 2018 - Jan 2020
• 

  Zimmer Biomet EMEA

  Jan 2022 - now

  Providing Support to the EMEA Quality and Regulatory Organization to Ensure Quality and Regulatory Compliance.Product Registrations:• Assisting EMEA regions with the product registration process.• Maintaining the product registration database (MHRA).• Gathering and reviewing relevant documentation to facilitate product registration.• Supporting the implementation of Windchill International Registration Requests (IRR) process. Once implemented, overseeing, reviewing, and monitoring IRRs.• Managing Change Notifications in Windchill: processing and reviewing Change Notifications for relevant regions.• Assisting regions with tender requests by providing necessary information and documentation.Product Complaints:• Collaborating closely with the Complaint Processing team to support the Product Complaints process. This includes addressing follow-up questions, facilitating product returns, and preparing monthly reports.• Contributing to the EMEA harmonization project to ensure that processes are kept up-to-date. This involves reviewing, approving, distributing, and managing obsolete documents according to established EMEA guidelines.Training:• Ensuring all new/updated procedures are effectively communicated via ILearn in relevant countries to ensure compliance among our employees. Meno dettagli •Create and maintain regulatory affairs registrations and licenses in RIMS/GTS distribution control systems in support of regulatory controls for global product distribution.•Generate and communicate distribution control reports in a timely fashion.•Maintain records (objective evidence) per established procedures.•Perform and support User Acceptance Testing (UAT) as needed for RIMS and GTS.•Work closely with global RA teams and customer service to resolve issues related to GTS/distribution control blocks and maintenance of objective evidence.•Conduct appropriate gap analysis on the existing license master data and develop summaries using advanced Excel and other data analysis tools.•Upload and maintain RA data in RIMS and GTS system using automated upload tools and troubleshoot data errors as needed.•Ability to apply technical expertise in data mining and modeling tools to provide insights into distribution control data for RA and suggest appropriate measures for enhancement of existing processes.•Understanding of software validation and testing protocols.•Understanding of medical devices regulations and their use.•Understanding of distribution, logistics and order flow from various Enterprise Resource Planning (ERP) Systems used by the company to GTS.•Conduct training for the team members on tools and techniques for maintaining data integrity.Support the creation of training materials and work instructions.•Support the generation of queries, metrics and reports.•Maintain compliance with RA Procedures and Work Instructions.•Ability to work with cross-functional teams. Meno dettagli

  • Regulatory Affairs Systems Specialist

    Jan 2025 - now

  • Quality and Regulatory Affairs Specialist

    Mar 2024 - Apr 2025

  • Regulatory Affairs Specialist

    Jan 2022 - Mar 2024