Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Szczecin we are Business Centre that is 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 job is located in Coloplast Business Centre in Szczecin, Poland. The team is involved in the development of regulatory strategies and registration of medical devices in various countries around the world. You will participate in writing and reviewing of documentation and will be responsible for ensuring that the technical file supporting our products is in compliance with relevant regulatory requirements. As we constantly strive to improve existing procedures, systems and processes in Coloplast, our team will also be expected to participate in cross-functional working groups building knowledge across the entire organization.
We would like you to work from our office in Szczecin, Poland, but there is also a possibility to work fully remotely.
The job
You will support the Regulatory Affairs Department in Denmark:
- Coordinate and compile regulatory files to ensure marked expansion and re-registrations within the allocated registration projects for medical devices
- Maintain registrations in defined areas to ensure regulatory compliance
- Surveillance of legislation and regulations for medical devices in defined areas
- Participate in optimising of registration processes
- Communicate regulatory requirements and regulations for medical devices effectively in RA HQ within defined areas
- Responsible for data entry within the registration tool, to continuously reflect a full overview of global product registrations
- Contribute to regulatory compliance for Coloplast product portfolio and business areas
Qualifications
Our ideal candidate for the job has:
- Degree within a scientific field
- Experience with regulatory activities within medical devices and/or other regulatory environment will be an advantage
- Knowledge of directives, standards and guidelines within the regulatory medical device area and/or other related regulatory areas (f.e. MDD, MDR, ISO 13485) will be an advantage
- Strong communication skills
- Fluent in both verbal and written English
- IT skills and knowledge in Excel
- Quality mindset
On a personal level you demonstrate our leadership principles and will easily become (if you aren't already) consumed by our vision: to make life easier for persons with intimate healthcare needs.
You are eager and a fast learner, and are very organized, structured with the ability to successfully lead multiple projects and manage deadlines. Last but not least you have great communications skills, and you enjoy interacting with different cultures. Come experience how our curiosity drives innovation and growth first hand.
What we offer?
We offer you a unique opportunity to grow within the organization, to develop personal abilities and to develop others in achieving their goals. You can expect to enter a global ‘one company’ that offers both great challenges and great rewards.
Furthermore, we offer:
- Private medical care,
- Sports card,
- Restaurant card,
- Holiday bonus and occasional cards
- Transportation co-funding
- Internal trainings
- Charity events
- Fantastic work atmosphere full of respect and partnership
And once Covid is gone and we’re back to the office, also:
- Modern workplace
- Great office location
- No dress code zone
- Great winter and summer events, and family picnics
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
