Regulatory Affairs Specialist
Miejsce pracy: Szczecin

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 job is located in Coloplast Business Centre in Szczecin, Poland. The team will be 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.

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
  • 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:
We are looking for an experienced Regulatory Affair Specialists with documented skills. 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 (e.g. MDD, MDR, ISO 13495)
  • 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
We offer:
  • Fixed term contract (min 12 months) with the possibility of extension
  • 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
Thats 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
If you are curious like we are, and want to know more about our company go to http://www.cpbc.pl

Pursuing 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 Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
By clicking the "Apply" or "Apply Now" button or by sending a recruitment application otherwise to Coloplast Business Centre Sp. z o.o., you agree for processing of your personal data for recruitment purposes in accordance with art. 6 par. 1 point b and f of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and of the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). You also agree to the processing of personal data included in the application form for future recruitments by Coloplast Business Center Sp. z o.o.
The administrator of personal data is Coloplast Business Center Sp. z o.o . with registered office in Szczecin, ul. Piastów 30, 70-064 Szczecin; contact to the Data Protection Officer: dataprotectionoffice@coloplast.com.
In addition, we would like to inform that:
  • Your personal data will be processed up to six months from the completion of the recruitment process.
  • You have the right to request access to your personal data, its rectification, erasure or limitation of processing and the right to object to processing, as well as the right to data portability.
  • You have the right to withdraw your consent at any time. The above does not affect the lawfulness of processing which was carried out on the basis of your consent before it was withdrawn.
  • You have the right to lodge a complaint with a supervisory authority - the President of the Office for Personal Data Protection.
  • Providing your personal data by yourself is voluntary, but necessary to participate in the recruitment process.
  • Decisions regarding the recruitment and selection process will not be taken in an automated manner.
Specjalista ds. Informacji Medycznej Szczecin Szczecin Koszalin Coloplast Business Centre Sp z o.o. Kołobrzeg Regulatory Affairs Specialist
APLIKUJ TERAZ

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