Opis stanowiska
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 temporary replacement agreement;
- 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.
If you have more questions, please contact our recruiter Kasia (kmas@dgs-diagnostics.com)
Furthermore we would like to inform you that the company has an internal reporting procedure, which is available at: demantcompliance - Make a report (codeofconduct.app)