Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Szczecin we have our Business Centre that works with global financial operations, orders administration, HR and IT support, Legal & Business Ethics, marketing & data analysis activities, and many others. If you have the right profile and the right amount of curiosity and ambition you can be a part of this exciting challenge. Curiosity works here!
About the department
The Biosafety Team is part of the Global Regulatory Affairs Group within Global Quality and consists of colleagues in Poland and Denmark. Our main responsibilities are to deliver biocompatibility documentation and ensure compliance with regulatory demands – with no compromises on product safety. We do so through literature studies, product testing and assessments according to international standards, which we then evaluate and document in writing.
Currently, we are looking for a new colleague for a temporary contract (12 months), with a possibility to be prolonged.
Activities and Responsibilities
- Toxicological / biological evaluation of medical devices in the framework of the Medical Device Regulation (MDR), ISO 10993-series and other relevant regulatory guidelines/requirements
- Development of biological evaluation strategies
- Searching for relevant literature and evaluation of toxicological studies and publications for critical human health effects
- Preparation of toxicological risk assessments for medical devices, based on the used raw materials, on extractable and leachable chemicals or on biocompatibility studies
- Overall evaluation of medical device chemical characterization data (e.g. hazard characterization of the leachable substances, identification of exposure levels for leachable substances, evaluation of limitations as applicable).
- Writing biological evaluation reports
Your profile as a Biosafety Specialist
- Masters or PhD degree preferably in medical biotechnology, engineering, toxicology, pharmacology, chemistry, biochemistry or biology
- Experience with biological evaluation and toxicological risk assessment are assets
- Knowledge/experience with the EU REACH regulation is an asset
- You speak and write English fluently – as we are an international organization, all our documentation is in English
- Ability to work in a team and self-motivated
- Quick learner, able to react to new challenges
We offer
- Remote work possibility
- Flexible working hours, Mon-Fri
- International work environment with Scandinavian culture
- Opportunity to use and develop foreign languages in daily work
- Fantastic work atmosphere full of respect and partnership
- Internal trainings
- Great company events
- Sports card
- Private medical care
- Restaurant card
- Holiday bonus and occasional cards
That's not all! We have even more for you, if working onsite:
- Modern workplace
- No dress code zone
- Delicious coffee and fresh fruits
- Transportation co-funding
Deadline
We will take candidates into the recruitment process continuously so do not hesitate to apply on-line via our job portal. We will close the position down once we have found the right candidate.
Poznaj
Coloplast Business Centre Sp z o.o.
71-064 Szczecin
Coloplast Business Centre (CPBC) is part of Coloplast, a global MedTech company dedicated to making life easier for people with intimate healthcare needs.
Based in Szczecin, CPBC supports Coloplast’s global operations across Finance, Data & IT, Digital Marketing, People & Culture, Order Administration, Customer Service, Quality and Medical Compliance, as well as Legal and Business Ethics. Together with our hub in Costa Rica, which supports Coloplast’s U.S. operations, we deliver highquality services globally. Regardless of the role or business area, everyone at Coloplast contributes to work that makes a difference.
Across all locations, we are united by a culture of collaboration, inclusion and personal empowerment. Guided by a strong sense of purpose, we work together to create solutions that improve the quality of life for millions of people around the world.s