(Junior) Regulatory Affairs Specialist

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.