Opis stanowiska podany przez pracodawcę:

 

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.

 

• 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.

Wymagania stawiane pracownikowi:

• 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.

Firma oferuje:

• 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.

• 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.

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