Regulatory Affairs Specialist

 

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 13485)
•    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)
•    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

 
Deadline Please apply with your English CV. We will contact candidates continuously and close the offer down once we find the best match to the team :) 
 
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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 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.
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