Biosafety and Chemical Compliance Specialist

Job title:

Biosafety and Chemical Compliance Specialist

Company:

Coloplast

Job description

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

That’s 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

Recruitment detailsPlease apply online with your CV in English.
We will review all applications continuously and invite selected candidates further to the recruitment process. We will close the offer down once we find the best match to the role.#LI-remotePlease apply by sending your application in English.If you are curious like we are, and want to know more about our company go toPursuing 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 .
Follow us on . Like us on .58656
#LI-CO

Expected salary

Location

Szczecin, zachodniopomorskie

Job date

Sun, 09 Mar 2025 03:21:10 GMT

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