We are now seeking an experienced
Regulatory Affairs Specialist for In Vitro Diagnostics
who would like to grow with us and move the innovative life sciences sector forward
About DIANA Biotechnologies
We are leading Czech biotechnology company with a great innovative potential. We focus on the development of products based on our cutting-edge research in the fields of molecular diagnostics and drug discovery. We have global ambitions and since our foundation in 2018 we already have achieved some of our goals. During COVID-19 pandemics, we were able to quickly develop one of the most innovative COVID-19 tests worldwide and we helped to increase the testing capacity of the whole country. As a result, we became the biggest Czech manufacturer of RT-PCR tests. Besides RT-PCR, we continue to focus on projects aiming to develop new molecular diagnostics, monoclonal antibodies and new drug candidates. This is possible thanks to our multidisciplinary team motivated to advance diagnostics and drug discovery.
We are a young and dynamic company being built by friendly and highly skilled colleagues, but at the same time we have already grown to a midsized company with around 100 employees and we have the ability to run long term and ambitious projects. If you join us, you will be part creation of a unique biotech company which is the first of its kind in the Czech Republic.
We are strengthening our Quality Assurance team and we are thus looking for an RA specialist.
What will be your responsibilities?
- You will work under supervision and guidance of our QA manager
- You will create and update technical documentation about our IVD products in English and Czech language. Applicable legislation will be mainly the Regulation (EU) 2017/746 of the European Parliament and of the Council, international standards related to our quality management system and ISO 13485 and related standards.
- You will ensure that all product documents are up to date and in accordance with current legislation.
- You will be involved in discussions with the developers and manufacturers of kits
- You will also communicate and coordinate the work with external consultants
- You will collect and periodically review feedback from our customers
- You will periodically review current legislation
Who are we looking for?
- Self-motivated professional with positive attitude and team spirit.
- You should have a finished master’s degree or equivalent education in biochemistry, molecular biology, pharmacology, chemistry or related fields.
- You should be proficient in both written and spoken English: IVD technical documentation is written mostly in English, some documents are in Czech.
- Technical understanding of the IVD products (such as nucleic acids isolation, RT-PCR kits etc.) is a must – we will provide you with detailed description and explanations.
- Detailed experience with writing the technical documentation for medical devices or in vitro diagnostics as well as detailed knowledge of the legislation is not necessary, but some experience is an advantage.
- You should be able to review literature and legislation and learn independently.
- You should work in highly organized matter and with attention to details.
What can we offer?
- Friendly and supportive environment
- Diverse work in a dynamic and unique biotech company
- Perspective of a long-term contract in a successful company
- Participation in the production of unique diagnostic products
- Possibility to gain detailed knowledge of directive 2017/746 and ISO 13485
- Opportunity to join the company at an early stage enabling your career development
- Support of further education, courses, trainings, thorough onboarding process
- Competitive salary and possibility of personal growth
- Various benefits, including 5 weeks paid vacation, meal voucher allowance, sick days, pension contribution and regular company events
- Full time employment contract
When applying, please send us your motivation letter (tell us about your ambitions, project goals and skills you can contribute) and CV (incl. list of publications and at least two reference contacts).