Regulatory Affairs Specialist (Replacement agreement)

Are you a meticulous and detail-oriented professional with a deep understanding of regulatory frameworks? Do you thrive in a fast-paced, ever-evolving industry where compliance is key? Look no further! We are searching for an exceptional Regulatory Affairs Specialist to join our passionate team.

Working with us you will receive:

• a chance to develop yourself in a Polish-Danish culture based on openness and trust;
• the opportunity to exchange experiences and develop skills in an international environment;
• a full introductory training;
• the possibility to learn the essential standards and regulations e.g. (EU) 2017/745, FDA 21CFR820, and many more;
• full-time work agreement in the international developing organization;
• flexible working hours and hybrid workplace;
• possibility to improve English in daily basis (courses offered);
• close cooperation with your team and manager - Laura Bednarz

What tasks are waiting for you?

• Ensure that regulatory requirements are fulfilled for medical device products.
• Coordinate and compile regulatory files to ensure registrations and renewals within the allocated registration projects.
• Maintain registrations in defined areas to ensure regulatory compliance.
• Ensure that the Regulatory Affairs System is updated and data are validated.
• Support the organization in relation to Regulatory Affairs related issues.
• Cooperate with notifying body and quality during audits.
• Identify current and applicable standards for medical devices including applicable guidelines (MDCG, MEDDEV, IMDRF);
• Support and identify regulatory requirements in close cooperation with development team and project stakeholders.

It would be great if you have:

• A bachelor’s or master’s degree in audiology, health care, life science, engineering or other relevant technical or scientific degree;
• Regulatory knowledge within Medical Devices or similar;
• 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;
• Proficient in English – written and spoken;
• Excellent written and verbal communications skills.