Rebecca Russo Email & Phone Number

Charlotte, North Carolina, United States

Stockholm, Se

Manage regulatory activities for global innovation and lifecycle management projects associated with compression therapy, orthopedic soft goods, and fracture management products. Key responsibilities include:- Support implementation of a UDI platform to ensure compliance for global UDI requirements- Review and update technical files as necessary- Collaborate with cross functional global teams to implement new solutions- Review and assess claims and corresponding substantiation- Support complaint handling and reportability decisions

Stockholm, Se

Moved into a new role combining responsibilities for the North America Market and Legal Manufacturer Charlotte. Continued to support the North America Market while adding support for Class I and Class II medical device design and development activities. Acted as Regulatory representative within Quality Review Boards and Complaint Handling. Evaluated complaints, assessed reportability, and supported corrections and removals, as applicable.

Stockholm, Se

Managed medical device compliance in the North America Market, supporting the commercial organization with new product introduction and lifecycle management. Covered all medical devices sold in the North America Market including orthopedic soft goods, compression therapy, fracture management, wound care, incontinence, and menstrual products. Key responsibilities included:- Review and approval of marketing material, claims, and product labeling intended for the United States and Canada - Assisting commercial team with new item setup and product information requests from customers and tenders- Collaborating with global colleagues to assess and determine regulatory strategy for new product introductions and changes throughout the product lifecycle- Evaluating product classification and applicable requirements- Supporting and maintaining product and site registrations with competent authorities - Acting as Regulatory representative within Quality Review Boards and Complaint Handling- Conducting complaint evaluations and assessing reportability- Determining impact of changes in the regulatory landscape, updating/establishing processes, and training impacted stakeholders

Amsterdam, Noord-Holland, Nl

Responsible for Personal Health Market Regulatory activities in the United States and Canada, teaming up with colleagues worldwide to ensure efficiency and alignment.- Monitored developing regulations and changes impacting product stewardship. Aided in assessment of impact to product portfolio. Supported and collaborated with businesses and domain owners in planning and implementing changes- Drove market approbation activities for new product introduction. Investigated applicable requirements for new propositions. Reviewed and advised on product, claims, labeling, and packaging conformance with regulations and standards- Supported global regulatory strategies and submissions to competent authorities- Conducted registration and reporting for Federal and State regulations- Partnered with complaint handling units to promptly manage complaints. Created and submitted Medical Device Reports on behalf of businesses- Assisted with deployment of global Quality Management System procedures, training, and tools to ensure compliance with 21 CFR 820, ISO 13485, and ISO 9001. Collaborated with stakeholders to manage impact and create localized add-on documents- Supported activities to minimize scrap. Worked with subject matter experts in various businesses to develop protocols, processes, and specifications for establishing third-party refurbishing activities

Amsterdam, Noord-Holland, Nl

Supported compliance with regulatory, customer, and quality management system requirements applicable to consumer products, pesticide devices, children's products, and medical devices in the Personal Health North America Market.- Managed retailer compliance program across all brands and customers. This included coordinating compliance to retailer testing, dangerous goods, sustainability, WERCS registrations, and other customer driven compliance initiatives- Assisted businesses with approbation activities for new product introduction. Reviewed and provided guidance on product, labeling, packaging, and claims list requirements in accordance with Federal and State regulations, applicable standards, and clinical substantiation. Established and maintained licenses and registrations, as needed- Supported complaint handling activities for the United States and Canada including the creation and submission of Medical Device Reports to the US FDA on behalf of applicable businesses- Tracked, trended, and evaluated customer complaints impacting Supply Chain Solution Centers- CAPA facilitator for Personal Health North America Market. Responsible for supporting CAPA owner, ensuring compliance to the global processes, timeliness of actions and milestones, and completeness of record- Provided quality management system and end to end initiative support. Contributed to the successful planning and deployment of corresponding procedures, training, and tools. Worked with process owners to create local add-on documents, as necessary- Prepared and participated in audits to support assessment of the quality management system - PathWise certified trainer for Technical Writing. Facilitated instructor led and virtual instructor led technical writing training as part of an initiative to train all CAPA facilitators to the material

Basel, Ch

Tasked with finding and evaluating devices and/or services to meet a newly identified customer need from a specific regional market within a global organization.- Worked with the commercial lead to fully define market needs. Converted needs into high-level technical requirements, and evaluated internal resource capabilities, with insights from key stakeholders within R&D- Assessed regional versus striated local market requirements from a regulatory standpoint to evaluate project feasibility and further define project requirements

Ingelheim Am Rhein, Rhineland-Palatinate, De

Performed projects and analysis to ensure new field sales systems were utilized in a consistent and compliant manner.- Led efforts to unify field sales force national account planning activities resulting in best practice development for consistent and compliant account planning across field sales- Gathered requirements to revise and update national standards for field sales force roles which ensured accuracy and uniformity of field sales expectations- Identified remote meeting technology best practice opportunities and trained staff on these practices resulting in greater usage of the new system in its totality

Stony Brook, Ny, Us

Created and analyzed the initial triggering mechanism for a novel rehabilitation device. Assisted with participant recruitment, informed consent, and running of the experimental procedure for ongoing studies within the Locomotor Learning Lab.

Stony Brook, Ny, Us

Utilized social media and implemented marketing plans to meet attendance and revenue goals. Communicated with current and potential corporate partners to ensure contract fulfillment while gaining new partners.

Stony Brook, Ny, Us

Formed and mentored Introduction to Biomedical Engineering project groups.

Stony Brook, Ny, Us

Prepared nano-metal oxide and porcine skin samples used for gathering nano-metal oxide tissue penetration insights. Developed standard operating procedure for sample production.

Stony Brook, Ny, Us

Developed, presented, and evaluated course materials. Assisted with lectures and assessments.

Leverkusen, North Rhine-Westphalia, De

Completed experiments and analysis in an aseptic environment to determine best candidates for progression through the development process. - Completed shake flask and fed batch shake flask work for backup and evaluation testing in a sterile environment- Conducted monoclonal antibody fed batch fermentation, 2L to 200L including setup, breakdown, sampling, and HPLC analysis- Maintained perfusion reactors, biochemistry analyzers, and image-based cell counters/analyzers for accurate cell culture analysis

Leverkusen, North Rhine-Westphalia, De

Collaborated with the Human Factors Team on product ideation for a new blood glucose system. - Conducted Radio Frequency and Electrostatic Discharge Testing to confirm product compliance- Evaluated competitive products and developed product design requirements used for blood glucose system prototype development- Researched and developed product ideas culminating in usability study protocol development, execution, and moderation which provided customer specific insights to inform the ideation process

Master Of Business Administration - Mba, Concentration: Strategy & Entrepreneurship

Master Of Engineering Management (Mem), Engineering Management

Bachelor Of Engineering (Be), Biomedical Engineering