zachodniopomorskie / Szczecin

Biosafety and Chemical Compliance Specialist

dzisiaj

Miejsce pracy: Szczecin

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 and Chemical Compliance Team is part of the Global Quality, Regulatory Affairs & Sustainability department. Our team, located in Poland and Denmark, ensures compliance with regulatory requirements while maintaining the highest standards of product safety.
We achieve this through literature review, product testing, and assessments based on international standards, which our team analyzes and documents. Our key focus areas include biocompatibility evaluations and chemical compliance with global regulations.

Activities and Responsibilities

Conduct toxicological and biological evaluations of medical devices in compliance with MDR, ISO 10993-series, and other regulatory guidelines.
Develop biological evaluation strategies and prepare biological evaluation reports.
Search and analyze scientific literature to assess toxicological risks and critical health effects.
Perform toxicological risk assessments based on raw materials, extractable and leachable chemicals, or biocompatibility studies.
Evaluate medical device chemical characterization data, including hazard characterization, exposure level identification, and limitation assessments.
Ensure compliance with the REACH regulation and manage processes related to chemical registration and the safe use of chemicals.
Manage information obligations and oversee the monitoring of hazardous chemicals identified under REACH.
Monitor regulatory changes in chemical compliance and assess their impact on product compliance.

Your profile as a Biosafety and Chemical Compliance Specialist

Master’s or PhD in medical biotechnology, engineering, toxicology, pharmacology, chemistry, biochemistry or biology.
Experience in biological evaluation and toxicological risk assessment is an asset.
Experience in chemical compliance, preferably in the medical device or related industry.
Knowledge of MDR, REACH, California Proposition 65, and other relevant regulations.
Fluency in English (written and spoken) – all documentation is in English.
Ability to work both independently and as part of a team in an international environment.
Strong analytical skills and a proactive approach to new challenges.

We offer

No probation period – long-term contract from the start.
Hybrid and onsite work from our office in Szczecin / Remote work possibilities (from Poland).
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 available in CPBC Academy.

Thats not all! We have even more for you

Modern workplace.
No dress code zone.
Great company events.
Sports card.
Private medical care.
Transportation co-funding.
Restaurant card.
Holiday bonus and occasional cards.
Delicious coffee and fresh fruits.

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 16.000 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.