Senior Regulatory Approval Officer
CurrentResponsible for supporting the product launch and business continuity in key markets across EMEA ensuring compliance with the local regulatory requirements.
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Anita Kecskes is listed as Senior Regulatory Approval Officer at OMRON Healthcare EMEA, a with 198 employees, based in Amsterdam, North Holland, Netherlands. AeroLeads shows a matched LinkedIn profile for Anita Kecskes.
Anita Kecskes previously worked as Product Launch Specialist Team Lead at Omron Healthcare Europe and Product Launch Specialist at Omron Healthcare Europe. Anita Kecskes holds Master Of Arts (M.A.), Archeology from Eötvös Loránd University.
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In the last 9 years I’ve developed my career working in the medical device manufacturing industry. Throughout this time I have worked in various functions, departments and on over 100 new product introductions.I’m specialized in coordinating new product launch preparation and product lifecycle magement projects for the EMEA region. By combining my thoroughness with the ability to manage multiple projects of shifting priorities and strong communication skills, I have had a significant contribution to bringing healthcare products from manufacturer to the consumer. I’m most proud of the projects that resulted in launching new, innovative products that can truly change people’s lives by bringing healthcare in their focus. I gain my energy from these projects and do not shy away from complex problems and challenges.In my non-professional side I love spending time with my daughters, reading, exploring gastronomy and bing-watching Netflix shows.
Listed skills include Microsoft Office, Museums, Research, Photoshop, and 15 others.
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Hoofddorp, North Holland, Netherlands
Responsible for supporting the product launch and business continuity in key markets across EMEA ensuring compliance with the local regulatory requirements.
Hoofddorp, North Holland, Netherlands
In this position I have a complex role of Product Launch process lead responsible for cross-functional collaboration and manager of an operational team working on both new launches and product changes. I As designated Product Launch process lead I am responsible for:- steering, monitoring and supporting new Product Launch projects in all product categories by leading cross-departmental project status meetings within the European division and with the headquarters in Japan; -… Show more In this position I have a complex role of Product Launch process lead responsible for cross-functional collaboration and manager of an operational team working on both new launches and product changes. I As designated Product Launch process lead I am responsible for:- steering, monitoring and supporting new Product Launch projects in all product categories by leading cross-departmental project status meetings within the European division and with the headquarters in Japan; - coordinating the operational launch preparation activities of the departments (Marketing, Quality Assurance, Regulatory Affairs, Supply Change Management, Technical Customer Service) as well as the work of external translation and design agencies involved in the Product Launch Process; - planning and leading the approval stage gate meetings with key stakeholders (Board of Directors), - providing time-, budget- and risk-management for all business critical projects; - co-leading process optimization projects. Additionally, as a People Manager I have been responsible for supervising and coaching the Product Launch Specialists team that work on operational projects. Show less
Amsterdam Area, Netherlands
In this role I gained in-depth knowledge of the artwork development process and product specifications change management by working on hundreds of SKUs. Such projects require complex coordination skills and keen attention to details in order to reach a time- and and cost-efficent execution. Specialist in artwork (instruction manual and sales packaging) development for entire portfolio by: - coordinating new artwork development for in-parallel running various product launch projects;… Show more In this role I gained in-depth knowledge of the artwork development process and product specifications change management by working on hundreds of SKUs. Such projects require complex coordination skills and keen attention to details in order to reach a time- and and cost-efficent execution. Specialist in artwork (instruction manual and sales packaging) development for entire portfolio by: - coordinating new artwork development for in-parallel running various product launch projects; - preparing the artwork development planning and aligning with the R&D teams in Japan/China/Vietnam to ensure timely execution in line of the launch schedule; - managing product specification change (renovation) projects across various product categories (cardiovascular, respiratory, active healthcare) for in average 50 product versions (SKUs) per year; - coordinating the work of external translation and packaging design agencies and aligning with business partners to ensure local regulatory requirements are met; - maintaining product technical documentation database and providing business partners with up-to-date product documentation; - preparing product information sheets for regulatory and marketing/sales use;- adhering to the QMS procedures and regularly updating tools (guidelines, SOPs, checklists) in line with the changes in the medical device regulations; Have contributed to more than 20 successful product launch projects in the last 5 years, including the global launches of innovative flagship products such as DuoBaby, Evolv and Complete. Show less
Amsterdam Area, Netherlands
In this role my main responsibility was to provide overall administrative support to the Product Launch team by:- executing Product Specification Changes in active product portfolio; - gathering, sending and tracking marketing materials to business partners. -working on various Product Launch projects by coordinating operational tasks and creating/handling product documentation; - updating the centralized product launch documentation library; and - sample inventory… Show more In this role my main responsibility was to provide overall administrative support to the Product Launch team by:- executing Product Specification Changes in active product portfolio; - gathering, sending and tracking marketing materials to business partners. -working on various Product Launch projects by coordinating operational tasks and creating/handling product documentation; - updating the centralized product launch documentation library; and - sample inventory management. Show less
Amsterdam Area, Netherlands
SPARK is an international NGO (with 9 regional offices) that manages projects and programmes for developing entrepreneurship and higher education in Western Africa, Southeast Europe and in the Near East. In this position as an office manager intern I was responsible for providing overall assistance in various fields of administration, office management, recruitment and quality assurance.
Hungary
Overseeing various project and administration related tasks, communicating with authorities and contractors, organizing conferences, book reviews and internal events. As a field expert I have coordinated, scheduled and supervised the field and post-processing work of teams of 20-70 in various archeological sites.
Other employees you can reach at omron-healthcare.com. View company contacts for 198 employees →
Alessandra Carvalho Carvalho
Colleague at Omron Healthcare EmeaSão Paulo, Brazil
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Razib Hassan
Colleague at Omron Healthcare EmeaBangladesh
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Nayer Kareem
Colleague at Omron Healthcare EmeaEgypt
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Katarzyna Patynowska
Colleague at Omron Healthcare EmeaWarsaw, Mazowieckie, Poland
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Elena Calinescu Pop
Colleague at Omron Healthcare EmeaOss, North Brabant, Netherlands
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Piotr Krolik
Colleague at Omron Healthcare EmeaWarsaw, Mazowieckie, Poland
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Maria Kim
Colleague at Omron Healthcare EmeaThe Hague, South Holland, Netherlands
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Evelina De Boer
Colleague at Omron Healthcare EmeaAmsterdam Area, Netherlands
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Devi Retnowati Anggraeni
Colleague at Omron Healthcare EmeaAmsterdam, North Holland, Netherlands
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Jijeesh Unnikrishnan
Colleague at Omron Healthcare EmeaDubai, United Arab Emirates
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Quick answers generated from the profile data available on this page.
Anita Kecskes works for OMRON Healthcare EMEA.
Anita Kecskes is listed as Senior Regulatory Approval Officer at OMRON Healthcare EMEA.
Anita Kecskes is based in Amsterdam, North Holland, Netherlands while working with OMRON Healthcare EMEA.
Anita Kecskes has worked for Omron Healthcare Emea, Omron Healthcare Europe, Stichting Spark, and Hungarian National Museum, National Heritage Protection Centre, Salisbury Co..
Anita Kecskes's colleagues at OMRON Healthcare EMEA include Alessandra Carvalho Carvalho, Razib Hassan, Nayer Kareem, Katarzyna Patynowska, and Elena Calinescu Pop.
You can use AeroLeads to view verified contact signals for Anita Kecskes at OMRON Healthcare EMEA, including work email, phone, and LinkedIn data when available.
Anita Kecskes holds Master Of Arts (M.A.), Archeology from Eötvös Loránd University.
Anita Kecskes is listed with skills including Microsoft Office, Museums, Research, Photoshop, Corel Draw, Product Marketing, Marketing, and Healthcare.
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