Regulatory Affairs Specialist

Regulatory Affairs Specialist

Coloplast

Szczecin, Poland

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.

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