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(Junior) Regulatory Affairs Specialist
Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Szczecin we opened Coloplast Business Centre that is responsible among others for financial operation of the company but as well as cusomer service and IT operations. If you have the right profile and the right amount of curiosity and ambition you can be a part of this exciting challenge.
About the department
The job is located in Coloplast Business Centre in Szczecin, Poland. The team will be involved in the development of regulatory strategies. We 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.
You will support the Regulatory Affairs Managers in Denmark in terms of:
- the creation and maintenance of a documentation overview and submission files for product registrations incl. STED formats (Summary Technical Documentation)
- establishment of a GAP analysis of available documentation according to regulatory requirements
- identify standard work needed for compiling of documentation/submission files in line with Regulatory, according to instructions and procedures
- responsible for parts of the RA strategy, according to projects plans, such as:
Implementation of STED files according to templates
Evaluate the quality of the documentation on high level for specialists to confirm
Our ideal candidate for the job has:
- Degree within a scientific field
- Min. 1 year experience with regulatory activities within medical devices and/or other regulatory environment
- Knowledge of directives, standards and guidelines within the regulatory medical device area and/or other related regulatory areas
- Knowledge of design control and regulatory approvals from a documentation perspective
- 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 a perfect match if...
...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.
We work for making life easier for consumers with intimate healthcare needs.
We are always looking for new ways to move forward and people to move forward with. We explore, learn and look for new ways of doing things. We are curious and curiosity is what drives us to keep improving. If you have the skills and the curiosity to lead us down new paths, we could be a perfect match.
Please apply by sending your application in English, deadline for applications is set for 30/06/2018.
We will take candidates into the recruitment process continuously and will close the position down once we have found the right candidate.
More about us on http://www.cpbc.pl/.
We care about the candidate experience, therefore we support the Friendly Recruitment union https://przyjaznarekrutacja.pl/czlonkowie/.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 10.000 people and with products available in more than 130 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. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.