Sysmex Italia is a subsidiary of Sysmex Europe SE, specializing in health technology, specifically in vitro diagnostics.

Founded in 2008, it focused its efforts on cancer diagnosis, and have evolved and grow to the haematology sector, supporting healthcare professionals and patients around the world with a broad range of medical diagnostic products and solutions in a variety of fields.

We're looking for an Quality and Regulatory Affairs to help us boost the company to the next level. We want you to be oriented for your tenacity and results.

You're hard-working, motivated to make a big impact, and you persevere until the job is done.

Initiative and growth mindset. You often come up with ingenious ways to reach your goals. In addition, you're constantly analysing the market to implement new ideas and opportunities.

As an expert professional in your area, you are in charge of the preparation and submission of public tenders, collaborating with internal stakeholders, such as marketing, sales, legal, operations and subject matter experts.

Carry out all the activities related to the assigned procedure, from the initial analysis phases aimed at participation, to the post-award phase.

Preparation of the economical offer accordingly to the commissions of the commercial functions.

Why work with us at Sysmex?

Sysmex offers a work environment that embraces diversity, collaboration and simply allows you to be yourself.

Our products aim to help improve patient life and well-being, but what about the well-being of our colleagues? We provide a workspace that appreciates and rewards effort and commitment. We understand our company as not solely being a workplace.

We strongly believe that joint understanding and a solid framework are essential parts of maintaining a value-driven corporate culture.

That is why we established references reflecting our beliefs in acting with colleagues, partners, suppliers and customers.

Job requirements

In this role you will:

Integrated management system:

- Development of process map and written procedures.

Control of documentation.

- Develop planning for internal audits.

- Design and monitor processes KPIs.

- Monitoring of non-conformities identified by departments, and internal and external audits, and customer satisfaction.

- Manage complaints from customers.

Sustainability and CSR:

- Monitor environnemental KPIs.

- Support CSR activities.

Regulatory:

- Ensure compliance with regulatory legislation.

- Control of technical documentation.

- Support to business units and public tenders department for requirements from customers.

- Support in vigilance incidents.

- Register products.

- Control on advertising of medical devices.

Compliance:

- Support on Ethical Code compliance.

- Reporting of grants.

What you need to be successful:

• University Education in Health Sciences or related to the position to be filled.
• Fluent in English and Italian
• Valuable masters degree or Training in integrated management, Quality and/or Environmental Systems.

General professional experience:

• Experience in ISO certification and audits.
• Experience in project coordination.
• Experience working with Microsoft Office, excel in particular.
• Experience working with Microsoft Visio or process modelling tools.
• Project management
• Process management and business process model and notation
• ISO 9001 Internal audits
• ISO 14001 internal audits
• IVDR and MDR
• Regulatory

Professional experience for the position:

• Previous minimum experience of 3 years in Regulatory Affairs and/or Quality Assurance.

What's in it for you?

One of our biggest goals as a company is the health and well-being of our employees.

And so, we offer the following:

• Mobile working
• Flexible time and work-life-balance
• Ticket restaurant
• Canteen
• Campus training platform for the growth of your knowledge and skills