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
CPBC Labelling Team was established in May 2015 and currently supports more than 100 countries around the world. The team is responsible for creating and maintaining labels and instruction for use (IFU) according to local law requirements, so our patients can learn more about product descriptions, warnings and usage recommendations. The team cooperates on a daily bases with Global Labelling team in Denmark and with various business units, such as Regulatory Affairs, Global Marketing, Clinical Research and Production Sites.
About the job
The job of the Global Labelling Team Leader is to lead the Labelling team in CPBC with all assigned tasks and to secure a solid labelling compliance understanding in the team. Team Leader manages the communication between CPBC team and Global Labelling Team, coordinates projects and activities aligned with Global Labelling Team and secures a holistic understanding of the labelling process and relevant stakeholders.
We are expecting you to work directly from our office in Szczecin. We can offer you support with relocation, if needed.
- Team management and taking care of team members’ development
- Prioritise and execute daily tasks in alignment with the Head of Global Labelling
- Preparation of labels and IFU’s for submission according to the MEP list and adhere to agreed deadlines and instructions
- Deliver Labels and IFU at time for IVS launches
- Monitor and report actual resource allocations. Escalate to Head of Global Labelling & Global Operations Support Director when additional resources are needed
- Handling 1st line support for label issues in production
- Follow-up on questions from global and local stakeholders
- Support relevant stakeholders in HQ by providing appropriate information
- Participate in relevant internal and external audits
- Participate in development and maintenance of global labelling processes within the company
- Propose improvement areas within Global Labelling
- Contribute to regulatory understanding and good documentation practice
- Master or bachelor’s degree in a relevant scientific field
- 2+ years of experience within the Quality field, preferably in medical devices, or similar
- 2+ years of experience in a leadership position
- Knowledge of directives, standards and guidelines within the regulatory medical device area and/or other related regulatory areas - preferable
- Fluent in both verbal and written English
- Good analytic and Excel skills
- Quality Systems & Processes understanding
- Ability to perform technical writing & technical documentation managing
- Global business understanding
- Project management skills
- Self-management and people management
- Structured and result oriented
- Analytical and capable of digesting complex data without losing the overall picture
- Tactical management of stakeholders
- 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
- Competitive salary with attractive benefit package
- Opportunity to use and develop foreign languages in daily work
- Fantastic work atmosphere full of respect and partnership
- Internal trainings
- 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
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.
Poznaj
Coloplast Business Centre Sp z o.o.
71-064 Szczecin
Coloplast Business Centre (CPBC) is part of Coloplast, a global MedTech company dedicated to making life easier for people with intimate healthcare needs.
Based in Szczecin, CPBC supports Coloplast’s global operations across Finance, Data & IT, Digital Marketing, People & Culture, Order Administration, Customer Service, Quality and Medical Compliance, as well as Legal and Business Ethics. Together with our hub in Costa Rica, which supports Coloplast’s U.S. operations, we deliver highquality services globally. Regardless of the role or business area, everyone at Coloplast contributes to work that makes a difference.
Across all locations, we are united by a culture of collaboration, inclusion and personal empowerment. Guided by a strong sense of purpose, we work together to create solutions that improve the quality of life for millions of people around the world.s