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.
About the job
Biosafety Team Leader is a people manager requiring Biosafety expertise in order to develop the team and support Coloplast business and requirements in most optimal way. Role reports dotted line to Head of Biosafety in HQ in order to follow the global direction for Biosafety as well as set right priorities for the team.
Responsibilities
- Lead the assigned team of specialists ensuring timely and high-quality delivery of assigned projects,
- Ensure proper communication and alignment between CPBC team and HQ Biosafety
- Strive towards development of competences in the Biosafety unit in alignment with Head of Biosafety
- Coordinate the delivery of information for biocompatibility of Coloplast products and compliance with regulatory demands
- Ensure optimal ways of knowledge transfer and sharing between HQ and CPBC teams as well as relevant task split and process setup
- Participate in cross-functional projects
Requirements
- Master’s degree within a relevant scientific field (eg. biochemistry, biology, chemistry, or pharmacology).
- +2 years experience within the biosafety field for medical devices or similar
- +2 years leadership experience
- Knowledge of biological evaluation and toxicological risk assessment
- Knowledge of relevant standards and legislation (for example: ISO13485, Medical Device Directive, FDA-part 820, Health Canada Device regulations etc.)
- Knowledge of directives, standards, and guidelines within the regulatory medical device area
- Knowledge of chemical legislation within Europe
- Fluent in both verbal and written English
- No probation period – long-term contract from the start
- Onsite or hybrid work from our office in Szczecin
- Challenging tasks and growth opportunities in a motivating work environment
- Gaining experience in an international organization
- Competitive salary with attractive benefit package
- Opportunity to use and develop foreign languages in daily work
- Fantastic work atmosphere full of respect and partnership
- Internal trainings
- Modern workplace
- No dress code zone
- Great winter and summer events, and family picnics
- Delicious coffee and fresh fruits
- Private medical care
- Sports card
- Transportation co-funding
- Restaurant card
- Holiday bonus and occasional cards
Please apply with your English CV. We will contact candidates continuously and close the offer down once we find the best match to the team :)
Poznaj
Coloplast Business Centre Sp z o.o.
Coloplast opracowuje produkty i dostarcza usługi ułatwiające życie osobom z dolegliwościami o bardzo osobistym charakterze. W Coloplast Business Centre świadczymy wsparcie z zakresu księgowości, IT, administracji zamówień, dokumentacji medycznej czy marketingu. Szukamy synergii pomiędzy tymi funkcjami dla tworzenia udoskonaleń i nowych możliwości.Wspierając codzienną pracę Coloplast na całym świecie, czynimy łatwiejszym życie naszych pacjentów.