Biosafety Specialist

Coloplast Business Centre Sp z o.o.

Szczecin

1 dzień temu

Biosafety Specialist
Miejsce pracy: Szczecin


Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Coloplast Business Centre we are responsible for global financial operations, orders administration, HR and IT support, 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!


Do you want to be part of the Coloplast Biosafety Team? 


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.
 

Welcome to the Biosafety team

 
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.

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
  • Monitoring and interpretation of legislation and standards relevant for biological and chemical safety
Your profile as a Biosafety Specialist:
  • 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.
We offer
  • 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
That's not all! We have even more for you!
  • 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
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.

andidate.

Please apply by sending your application in English.
If you are curious like we are, and want to know more about our company go to http://www.cpbc.pl

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.


Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
By clicking the "Apply" or "Apply Now" button or by sending a recruitment application otherwise to Coloplast Business Centre Sp. z o.o., you agree for processing of your personal data for recruitment purposes in accordance with art. 6 par. 1 point b and f of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and of the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). You also agree to the processing of personal data included in the application form for future recruitments by Coloplast Business Center Sp. z o.o.
The administrator of personal data is Coloplast Business Center Sp. z o.o . with registered office in Szczecin, ul. Piastów 30, 70-064 Szczecin; contact to the Data Protection Officer: dataprotectionoffice@coloplast.com.
In addition, we would like to inform that:
  • Your personal data will be processed up to six months from the completion of the recruitment process.
  • You have the right to request access to your personal data, its rectification, erasure or limitation of processing and the right to object to processing, as well as the right to data portability.
  • You have the right to withdraw your consent at any time. The above does not affect the lawfulness of processing which was carried out on the basis of your consent before it was withdrawn.
  • You have the right to lodge a complaint with a supervisory authority - the President of the Office for Personal Data Protection.
  • Providing your personal data by yourself is voluntary, but necessary to participate in the recruitment process.
  • Decisions regarding the recruitment and selection process will not be taken in an automated manner.


Poznaj

Coloplast Business Centre Sp z o.o.

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