About

Magamról

I am HORTENZIA CSISZÁR, Experienced Product Safety and Compliance Expert

for childcare, toys, food contact articles and medical devices. Senior regulatory affairs specialist with strong background in analytical chemistry and mechanical testing.

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Safe New Products

Professional Awards Won

Why Choose Me

I Can Help You As Expert Or Consultant

to bring safe and compliant products to market.

My clients are
companies, enterprises, technicians who
manufacture, develop and sell
• food contact articles, packaging materials,
• childcare products, hygiene products, medical or electrical devices, that come into contact with food, skin, saliva.

I help customers to understand and monitor the complex and constantly increasing legal requirements and to integrate them efficiently into the development, marketing, and sales process.

My professional activities include
• training and consulting on regulatory affairs,
• identifying the necessary tests (chemical, mechanical and biological), and
• supporting and fulfilling compliance-related tasks and obligations (e.g. labelling, certification documentation, declaration of compliance, etc.).

Expert in Product Compliance, Risk Assessment, Regulatory Affairs

more than 28 years of professional experience in the field of strict product compliance in the pharmaceutical industry, safety assessment of childcare products, new product development, manufacturing technologies, risk assessment of new processes and compliance with new regulations.

As a qualified chemical engineer and analytical quality engineer

I have gained extensive industrial experience in the fields of pharmaceuticals, quality assurance, analytical chemistry, plastics and rubber development, mechanical and usability testing.

Master in Crisis Avoidance

I focus on crisis prevention and avoidance in quality management, quality assurance and regulatory affairs. I am a calm and reliable partner in a crisis.

Member of

MSZT, ISO 310 (WG1, WG2) CEN TC252 (WG5,WG6). I lead the work of the TC252 WG5 TG1 and ISO 310 WG2 TG1 working groups on chemical topics as project leader.

Testimonials

Recommendations from the professionals I have worked with

So that is why you will like to work with me too:

Her tremendous drive for results, her expertise and experience has been a huge asset for our team and for our project. It was always a pleasure to talk to her, to listen to her opinion and to get her worthwhile inputs. I like her honest behaviour, her clear communication style and diligence. I am really happy that she will support our project also in future, although we have to find a new way of cooperation. But I am convinced that this will be successful too.

Jürgen Hartmann

General Manager, THT Kabinburi

I worked with Hortenzia for 15 years. She is really an expert in the field of Compliance, Quality control, Standardization and Audit. Her analytical skill is really great, a very good team player and and come up with excellent alternative suggestions to any problem. She is really an asset for any organization.

Anil Skariah

General Manager, Thaimed Baby GmbH

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Years Professional Experience

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Years Professional Experience In Regulatory Affairs

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Years Professional Experience In Pharmaceutical Industry

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Years Experience In Managing Quality System

Experience

Professional experience

For 15 years, I have ensured the safety of childcare products manufactured and distributed under the MAM brand, as Product Safety and Compliance Manager.
The reliability and safety of MAM products was rewarded by the European Commission with a “Product Safety Award” in 2019.
During this time more than 50 new products had been developed without any regulatory or compliance incident.
Our team was responsible for supporting the quality, research and development, marketing and sales departments, so I was able to actively contribute to the development of new products and new raw materials.

Hortenzia CSISZÁR

Product safety and compliance expert

Clients

Companies That I Have Worked With

to develop more than 50 new products – without any regulatory or compliance incident.

WANT TO KNOW EVEN MORE ABOUT ME?

You can download my CV here, highlighting my medical technology competencies:

You can download my CV here, highlighting my product safety and compliance expertise: