Katarzyna Czarcińska

Katarzyna Czarcińska

Regulatory Affairs Specialist, Strategic Manufacturing @ Teleflex

About Katarzyna Czarcińska

Katarzyna Czarcińska is a Regulatory Affairs Specialist, Strategic Manufacturing at Teleflex Incorporated, with a background in quality management, sales, and laboratory assistance.

Current Title and Role

Katarzyna Czarcińska is currently employed at Teleflex Incorporated as a Regulatory Affairs Specialist specializing in Strategic Manufacturing. In this role, she manages regulatory planning for devices marketed in the European Union, the United States, Canada, and other global markets. Her responsibilities involve close collaboration with departments such as Marketing, Clinical, Research & Development, Engineering, and Quality, as well as interactions with authorities and Notified Bodies.

Previous Experience at Teleflex Incorporated

Before assuming her current position, Katarzyna worked as a Regulatory Affairs Specialist within Teleflex Incorporated's Business Unit from 2019 to 2021. During her tenure, she participated in MDSAP-Audits and Corporate Audits, contributing her expertise as a Subject Matter Expert. Her work encompassed various regulatory responsibilities aimed at ensuring compliance and quality for the company's medical devices.

Quality Management Experience at AMOR Gummiwaren GmbH

In 2019, Katarzyna Czarcińska worked for 7 months at AMOR Gummiwaren GmbH in Arnstadt as a Quality Management employee. Her tasks likely involved maintaining and improving the quality management systems to ensure that products and services met consistent standards and regulatory requirements.

Educational Background

Katarzyna Czarcińska holds a Master of Science in Management and Production Engineering with a major in Production and Services Management from Wroclaw University of Economics. She completed this degree from 2015 to 2017. Prior to that, she earned a Bachelor of Engineering in Biotechnology from Wroclaw University of Science and Technology, where she studied from 2011 to 2015. Additionally, she studied German as a foreign language at VHS Arnstadt-Illmenau from 2018 to 2019.

Early Career Roles

Katarzyna has held various roles in her early career, including working as a Sales Specialist at Jahn GmbH in Tambach-Dietharz from 2018 to 2019 and as a Laboratory Assistant at Electropoli Poland Sp. z o. o. in Lubusz District, Nowa Sol County, Poland, from 2016 to 2018. These roles helped her build a solid foundation in quality management, sales, and laboratory practices.

Professional Development and Certifications

Katarzyna Czarcińska is currently preparing for the Regulatory Affairs Certification (RAC) exam to further substantiate her experience and knowledge in the regulatory field. This certification will enhance her qualifications and demonstrate her commitment to maintaining high standards of regulatory competence.

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