Compliance Specialist
5 mesi fa
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries?
PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
Due to our continuous expansion, we are currently looking for a Compliance Specialist - Medical Devices to support one of our clients in Mirandola , Italy .
You will be responsible for : Assist in Quality Assurance (QA) and Regulatory Affairs (RA) activities related to biomedical devices Issue, review, and update Quality Management System (QMS) procedures Oversee Corrective and Preventive Action (CAPA) processes Manage Risk Management procedures Address and manage complaints related to medical devices Conduct audits in the Medical Device sector Provide support for various Regulatory Affairs projects related to medical devices Assist in CE marking processes Support the transition to Medical Device Regulation (MDR) certification Assist in extra EU registration processes Review Technical Documentation for compliance with MDR requirements Update Clinical Evaluation Reports and Post-Market Clinical Follow-up reports Conduct literature research using databases such as PubMed, Cochrane, Embase, Scopus About you : Bachelor's or Master's degree in Biomedical Engineering, Biotechnology, or a related field Minimum of 1 year of experience within the biomedical devices industry English language fluency in speaking and writing (at least B2 level) Location : Mirandola, Italy 100% on site job - very limited remote work Availability to travel up to 60 % of the time Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation.
PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
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