Product Quality and Compliance Specialist

Overview Job Overview We are seeking a dedicated Quality Assurance and Regulatory Affairs Specialist to join our team. As a key member, you will be responsible for ensuring the quality of our products and compliance with regulatory requirements. About the Role You will work closely with the Quality & Regulatory leader, supporting a wide range of QA and RA activities. This is a unique opportunity to take ownership of critical processes, grow with the company, and help shape the foundation of our quality and regulatory systems. Responsibilities Support quality inspection activities for incoming, in-process, and final product. Assist in managing quality documentation, calibration records, and internal audits. Participate in the handling of nonconformances, CAPAs, complaints, and root cause investigations. Maintain change control documentation and support process improvements. Collaborate with manufacturing partners and suppliers to ensure product and process quality. Assist in supplier qualification and audits. Contribute to trend analyses and continuous improvement initiatives. Regulatory Compliance Assist with preparation and maintenance of regulatory submissions (EU MDR, FDA, etc.). Support internal compliance with ISO 13485, FDA QSR, and other relevant standards. Maintain regulatory documentation and records for product files and technical files. Help monitor and interpret regulatory updates and communicate key changes to the team. Liaise with external partners, auditors, and consultants under the guidance of the manager. Requirements More than 5 years of experience in a QC / QA / RA role, ideally within medical devices (Class I / II / III). Familiarity with : ISO 13485 and FDA 21 CFR Part 820. MDR Regulation (EU) 2017 / 745 documentation and requirements. Risk management (ISO 14971). Medical device packaging and sterilization requirements. Document control and QMS software. What We Offer A dynamic and flexible work environment where autonomy is encouraged. A role with broad exposure across the entire product lifecycle. The chance to work with experienced professionals and make a real impact. Opportunities for learning and professional growth as the company scales. J-18808-Ljbffr

Location: Verona, Veneto, IT

Posted Date: 9/18/2025