Empowering individuals and organisations to grow

<aside> 💡 With a "can do" attitude I am a sparring partner for rebel leaders using the strengths of each individual team member to achieve the corporate goals together.

I question the status quo to improve existing processes, bringing relevant stakeholders together to define common goals.

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Hello, I am Alexander Kurys CV en .pdf

<aside> ☝ Fluent in the field of Integrated Management Systems with a hang for Digital Media & Cyber Security as well as hacking healthcare.

10+ years experience in strategic and operative management of SMEs in the MedTech, IT and testing industry.

I am passionate about (company) Culture, Leadership and getting things done.

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Passion

Founder Freedom Sailors (since 2022) Organising Viennas Distinguished Gentleman's Ride (2012-2022)

Work Experience

since 2023/03

Regulatory Affairs, Process & Quality Manager Operations, Neuroth International AG, Lebring (Austria)

🦻 Creating products for people who want to listen. In my position I am responsible for the compliance of a custom made device manufacturer under the EU MDR and PPE Regulations for EU and non-EU markets.

ISO13485, MDR, PPE (EU 2016/425), ISO14971, ISO22301, WEEE, EU-BATT

• Medical Device Consultant
• Person Responsible for Regulatory Compliance
• Operational Excellence

2023/02

Manager Quality Management & Integrated Management Systems, Österreichische Staatsdruckerei GmbH, Vienna (Austria)

ISO9001, ISO14001, ISO14298, ISO22301 ISO27001

• Integrated Management System Digitalisation

2019/11- 2022/12

Head of Quality Management, Bloom Diagnostics GmbH, Vienna (Austria)

Bloom Diagnostics is a MedTech Manufacturer of IVD tests for home use.

My Focus: Team Lead, Management Representative, DPO, PRRC, Lead Auditor, ISO9001, ISO13485, IVDD, IVDR, ISO27001, GDPR

• Integrated Management System Lead
• Organisational Development
• Digital Trust

2013/11-2019/10

Operations and Quality Manager, Arsenal Testhouse GmbH, Wolfsgraben (Austria)

Arsenal Testhouse is a certification institute for RFID devices (MIFARE, EMVCo, NFC).

My Focus: Operations & Quality Management, Internal Auditor, ISO17025

• Operations & Quality Management
• Corporate Development & Strategy
• Subsidy Management
• Controlling

2010/10-2015/03

Business Developer, FAME Investments AG, Vienna (Austria)

FAME Investments is an Asset Management and Business Consulting Group.

My Focus: Business Development & Project Management

• Development and Implementation of Business Ideas
• Project Management
• Strategy

Education

2002-2010

University of Vienna

Master’s Degree (Mag.rer.soc.oec.) International Business Administration

“Vor- und Nachteile von RFID im Logistik Management”

Certificates

ISO 27001:2013 Requirements (BSI)

„Person Responsible for Regulatory Compliance“ (PRRC) (Johner Institut)

Medizinprodukteberater / Medical device consultant (Johner Institut)