Praca: Biosafety and Vigilance Team Leader
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!
About the department
The Biosafety & Vigilance Team is part of the Global Regulatory Affairs Group within Global Quality and consists of colleagues in Poland and 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.
About the job
The job is located in Coloplast Business Centre in Szczecin, Poland. The aim of the role is to lead the team and the communication between CPBC and HQ Biosafety & Vigilance team. Also, to ensure optimal ways of knowledge transfer and sharing between HQ and CPBC teams as well as relevant task split and process setup.
- Prioritize and execute daily tasks in alignment with stakeholders within HQ Biosafety & Vigilance teams
- Understanding of and interpretation of quality data
- Analyse processes and find possibilities for optimization and improve system usage
- Ensure high level of performance within assigned teams, monitor results, set and measure KPIs
- Depending on background ~40-50% of workload will be operational (Biosafety, Chemical Compliance or Vigilance)
- Ensure proper level of knowledge and competence development within relevant area
- Can be asked for input, in internal and external audits
- Participate in development and maintenance of Regulatory procedures and instructions within the company
- Contribute to regulatory awareness and good documentation practice
- Master’s degree within a relevant scientific field (eg. biochemistry, biology, chemistry, or pharmacology).
- 2+ years of experience within the biosafety field for medical devices/or other environment
- 2+ years of leadership experience
- Knowledge of biological evaluation and toxicological risk assessment
- Knowledge of relevant standards and legislation (for example: ISO13485, Medical Device Directive, FDA-part 820, Health Canada Device regulations, Japanese QMS for Devices) with special focus on regulations for Vigilance (nice to have)
- Knowledge of directives, standards, and guidelines within the regulatory medical device area
- Knowledge of chemical legislation within Europe
- Fluent in both verbal and written English
- Advanced knowledge in Excel
- No probation period – long-term contract from the start
- Challenging tasks and growth opportunities in a motivating work environment
- Gaining experience in an international organization
- Opportunity to use and develop foreign languages in daily work
- Fantastic work atmosphere full of respect and partnership
- Support with relocation, if needed
Thats 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
- Private medical care
- Sports card
- Transportation co-funding
- Restaurant card
- Holiday bonus and occasional cards
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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