Senior Regulatory Affairs Specialist

Coloplast Business Centre Sp z o.o.
Szczecin
starszy specjalista (senior)
pełny etat
umowa o pracę
praca zdalna
rekrutacja online
dziś wygasa15 dni temu
Senior 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 departmentAbout the department

The team is located in Coloplast Business Centre in Szczecin, Poland and are looking for a Senior Regulatory Affairs Specialist. Regulatory Affairs team is part of the Global Regulatory Affairs department of Coloplast, which comprises over 70 colleagues from around the world. The team is involved in the development of regulatory strategies and registration of medical devices in various countries around the world. In this role, you will be involved in building regulatory intelligence across the organization and ensure successful devices global launches across different business areas.

The job

In this position, communicating and collaborating play a key role as you will be the ‘go-to’ person when it comes to regulatory matters involving your products and projects. We are looking for a new colleague who enjoys collaborating across functions and cultures. 

 

Key activities
  • Craft country-specific regulatory strategies and provide registration files and submissions/filing for new product introductions, maintenance of regulatory approvals and product changes for the assigned geographies, either directly or by coordinating with in-country regulatory affiliates who interact with local regulatory authorities
  • Act as regulatory liaison for assigned geographies by ensuring that local regulatory requirements, pathways and registration needs are anchored in global regulatory strategies and executed at a local level, through transparent and clear communication and focus on collaborative work and solution
  • Assess acceptability of proposed labeling and technical/clinical documentation to fulfill local regulatory registration needs, in collaboration with global and local counterparts
  • Assess transferability of global product claims per local requirements, and review advertising materials for regulatory compliance
  • Assist with import/export and trade compliance activities, good sales practices and requests supporting commercial activities
  • Support post-market surveillance activities
  • Report information into applicable data management systems and maintain internal/external regulatory databases
  • Monitor and analyze emerging regulatory intelligence for the assigned geographies
  • Participate in development, maintenance and implementation of regulatory procedures, instructions and systems

Your experience / qualification

  • Bachelor or Master of Science degree in regulatory science, life science, biomedical engineering, or other relevant scientific or legal field
  • Minimum 5+ years’ experience in regulatory affairs – preferably from the MedTech industry or a related field
  • In depth knowledge of regulatory legislation, standards, and guidelines for medical devices, in particular MDR, MDSAP, EN ISO 13485
  • Fluent in English
  • Very good MS Office skills

Your personal skills

  • Analytical, systematic and solution-oriented way of working
  • Strong commitment, initiative and sense of duty
  • Holistic thinking and an open-minded attitude
  • Experience of working in an international environment
We offer
  • No probation period – long-term contract from the start
  • Hybrid or remote work 
  • 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
  • Great company events
  • Sports card
  • Private medical care
  • Restaurant card
  • Holiday bonus and occasional cards
That's not all! We have even more for you, if working onsite
  • Modern workplace
  • No dress code zone
  • Delicious coffee and fresh fruits
  • Transportation co-funding
Please apply by sending your application in English.
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 12.000 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.


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Coloplast Business Centre Sp z o.o.

Coloplast opracowuje produkty i dostarcza usługi ułatwiające życie osobom z dolegliwościami o bardzo osobistym charakterze. W Coloplast Business Centre świadczymy wsparcie z zakresu księgowości, IT, administracji zamówień, dokumentacji medycznej czy marketingu. Szukamy synergii pomiędzy tymi funkcjami dla tworzenia udoskonaleń i nowych możliwości.Wspierając codzienną pracę Coloplast na całym świecie, czynimy łatwiejszym życie naszych pacjentów.