Experience

TestLine Clinical Diagnostics s.r.o.

• Czechia
• Biotechnology Research
• 1 - 100 Employee

• Regulatory Affairs Consultant

  • Oct 2023 - Present

• Regulatory Affairs Manager

  • Jun 2020 - Sep 2023

  • IVD medical devices with CE mark• Lead the registration process – EU and non-EU countries• Lead the local regulatory process• Preparation of documents and revisions for notified bodies• Implementation of IVDR 2017/746, including performance evaluation and scientific validity• Interaction with agencies and partners• Experience with ISO 13485, ISO 9001, ISO 14971, Regulation (EU) 2017/746 (IVDR), and European Directive 98/79/EC (IVDD)



Amaris Consulting

• Switzerland
• IT Services and IT Consulting
• 700 & Above Employee

• Consultant

  • Aug 2023 - Present

  IVDR clinical affairs IVDR clinical affairs



Freelance, self-employed

• Life Sciences Freelancer

  • Mar 2019 - Present

  • Medical Translator & Proofreader (EN→CS), friendly with CAT tools and machine translations, specializing in IVDs and medical devices, instructions for use, clinical performance studies, plans and reports, clinical trial materials, leaflets, healthcare apps for patients, patient-reported outcomes • Regulatory Affairs consultant and technical documentation writer with expertise in IVDR and RUO products, performance evaluation, drafting plans and reports, market access, notified body audits, development of corrective actions to address audit non-conformities • Flexibility, efficiency, punctuality, detail-oriented, time management, meeting deadlines, independent work in a fast-paced environment, effective communication and collaboration, prioritization of tasks, proactive issue resolution, problem-solving, strategic thinking, innovative solutions, focus on compliant and safe functional products • Continuous learner, up-to-date on technologies, regulations and best practices Show less



BioVendor Group

• Czechia
• Biotechnology Research
• 1 - 100 Employee

• IVDR coordinator

  • Sep 2021 - Aug 2023



CEITEC - Central European Institute of Technology

• Czechia
• Research
• 400 - 500 Employee

• Researcher

  • Jan 2015 - Dec 2018

  Research focused on chronic lymphocytic leukemia - one of most common types of blood cancer in adults. What have I experienced: • define problem, find its' cause and implement solution • identify tasks and build realistic timeline • work with large amount of information • collaborate with others • work with limited supervision • motivate others • work very effectively, prioritize pressing tasks, meet deadlines • be flexible Research focused on chronic lymphocytic leukemia - one of most common types of blood cancer in adults. What have I experienced: • define problem, find its' cause and implement solution • identify tasks and build realistic timeline • work with large amount of information • collaborate with others • work with limited supervision • motivate others • work very effectively, prioritize pressing tasks, meet deadlines • be flexible



University Hospital Brno

• Czechia
• Hospitals and Health Care
• 100 - 200 Employee

• Research and Development

  • Sep 2014 - Dec 2018

  Research focused on chronic lymphocytic leukemia - one of most common types of blood cancer in adults. What have I experienced: • process large amount of information • process confidential medical information • internal hospital database, MS Office - Excel, Powerpoint, Word, Sharepoint Research focused on chronic lymphocytic leukemia - one of most common types of blood cancer in adults. What have I experienced: • process large amount of information • process confidential medical information • internal hospital database, MS Office - Excel, Powerpoint, Word, Sharepoint



Various

• Various part time jobs in administrative and industry

  • Jun 2005 - Jul 2014

  • obtaining experience in large manufacturing plants performing various processes, working at animal farms, shops, office administrative, steward at expo, presenting new products • leading horse riding courses for children • organizing small events • MS Office, computer literacy, customer care, presenting, responsibility, quality assurance, safety assurance, animal welfare • experiencing international environment in Singapore and the United Kingdom • obtaining experience in large manufacturing plants performing various processes, working at animal farms, shops, office administrative, steward at expo, presenting new products • leading horse riding courses for children • organizing small events • MS Office, computer literacy, customer care, presenting, responsibility, quality assurance, safety assurance, animal welfare • experiencing international environment in Singapore and the United Kingdom



Department of Experimental Biology

• Higher Education
• 1 - 100 Employee

• Scientific apprenticeship

  • Nov 2010 - Jun 2014

  • Analyzing data, presenting, creating posters, writing academic texts, applying for grants and international internships • Learning scientific methods including fluorescent and confocal microscopy, western blotting, flow cytometry, human and animal cell cultures while focusing on experimental oncology • Providing support for colleagues, working effectively in team environment, improving technical skills • Analyzing data, presenting, creating posters, writing academic texts, applying for grants and international internships • Learning scientific methods including fluorescent and confocal microscopy, western blotting, flow cytometry, human and animal cell cultures while focusing on experimental oncology • Providing support for colleagues, working effectively in team environment, improving technical skills