Technical Documentation & IVDR Specialist (m/f/d)

Location: Brno, Czech Republic
Employment type: Permanent
Working hours: 40 hours/week (negotiable)
Employer: BioVendor - Laboratorní medicína, s.r.o.

About the company

BioVendor Group is an international group of companies focused on in vitro diagnostics.

For more than 30 years, we have believed that high-quality, fast, and reliable diagnostics are the foundation of successful treatment. Laboratory professionals, physicians, and patients are our reasons to keep seeking new paths and approaches. The courage to innovate makes us who we are.

What you will be working on:

You will collaborate closely with Regulatory Affairs, Quality Assurance, R&D, Manufacturing, and Marketing teams to support the development, maintenance, and regulatory compliance of innovative molecular diagnostic products. You will be joining our Molecular Diagnostics division based in Brno and Vienna.

Key Responsibilities

• Review and maintain technical documentation in compliance with IVDR Annex II & III and applicable standards.
• Act as the key user for the technical documentation management system.
• Coordinate the creation, update, review, and submission of technical documentation in collaboration with QA, RA, R&D departments, and the PRRC.
• Provide guidance on IVDR requirements and technical documentation expectations.
• Support the transition of products from IVDD/RUO to IVDR compliance.
• Conduct gap assessments and support CE-marking readiness activities.
• Manage technical documentation throughout the product lifecycle, including post-market surveillance activities.
• Deliver training and support cross-functional teams on IVDR documentation requirements.

What is important to us:  

• Master's degree (MSc) in Biology, Biochemistry, Molecular Biology, Life Sciences, or a related scientific field.
• Minimum of 3 years of experience in Quality Assurance, Regulatory Affairs, or a related function within the IVD, medical device, biotechnology, or life sciences industry.
• Good knowledge of IVDR and/or MDR requirements and their practical application.
• Working knowledge of GMP (Good Manufacturing Practice) requirements.
• Experience in a regulated environment is considered an advantage. Solid understanding of molecular biology and technologies and methodologies, including PCR and NGS.
• Fluent communication skills in English and either Czech or Slovak language are required.

What we can offer you:

BACKING – Strong global support

We are part of the global investment group ARCHIMED. ARCHIMED is focused on accelerating the development of healthcare industries and solutions to the benefit of people and patients around the world.

INNOVATION – In-house research & development

Our products empower diagnostic laboratories and healthcare professionals to provide accurate and reliable diagnoses for their patients. As a scientifically driven and innovative company, we continuously develop new products in-house, giving you the opportunity to work at the cutting edge of industry.

CULTURE – Creative & inclusive environment

We foster a free and creative work environment where everyone has the space to apply their unique skills. We value diverse experiences as a source of inspiration and a driver of innovative ideas and approaches.

DEVELOPMENT – Continuous learning opportunities

If you are passionate about learning and professional growth, we fully support your development through training, conferences, and workshops to expand your skills and knowledge.

TEAM SPIRIT – Collaboration & expertise

We highly value teamwork and a culture where colleagues help and advise one another. We are proud of our experts and their contributions.

HEALTH & WELL-BEING

We care about our employees’ well-being, both professionally and personally. Beyond benefits like MultiSport cards, we offer extra vacation time and additional days off to rest and recharge.