Biosafety Specialist

Then grab this opportunity to work with life cycle management for Coloplast marketed products and play an important role in supporting the biological safety of the Coloplast.
 

 
The Biosafety Team is part of the Global Regulatory Affairs Group within Global Quality and consists of 4 colleagues in Poland and 7 in 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.
 
“As a team, we use our knowledge of chemical substances and biological safety to support product development. So, we stay curious and open to input, and we collaborate across the company as well as with several international partners to make sure our customers can put their trust in our products,” says Joan Drejer, Director Global Regulatory Affairs Operations & Biosafety.
 
We would like you to work from our office in Szczecin, Poland, but there is also a possibility to work fully remotely. This is a maternity cover position for 12-18 months.

• 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
• Monitoring and interpretation of legislation and standards relevant for biological and chemical safety

• Masters or PhD degree preferably in toxicology, pharmacology, chemistry, biochemistry or biology
• Experience of risk assessment process and of in vivo and in vitro methods for safety / toxicology assessment 
• Experience with biological evaluation and toxicological risk assessment
• Experience in activities related to chemical compliance
• 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
• You are analytical, organized and capable of digesting complex data without losing the overall picture. Furthermore, you need to know how to navigate cross-functionally in a large international organization.

• Challenging tasks and growth opportunities in a motivating work environment
• Gaining experience in an international organization
• Competitive salary with attractive benefit package 
• Private medical care
• Sports card
• Transportation co-funding
• Restaurant card
• Holiday bonus and occasional cards

• Modern workplace
• No dress code zone
• Great winter and summer events, and family picnics
• Delicious coffee and fresh fruits
• Internal trainings
• Opportunity to use and develop foreign languages in daily work
• Development possibilities within the organization
• Fantastic work atmosphere full of respect and partnership

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.

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