Job Title:Quality Assurance / Regulatory Affairs Intern
Location:Monsano (AN)
Departments:Quality Assurance Regulatory AffairsAbout Us:
Chema Diagnostica is a SME in the diagnostic medical device industry, committed to providing high-quality solutions for improving patient care worldwide. We specialize inInVitroDiagnostic medical devices (IVD) and we are dedicated in maintaining compliance with standards and regulations to ensure the safety and performance of our devices.
Job Overview:
We are looking for a highly motivated and detail-oriented Stage Quality Assurance / Regulatory Affairs Intern to join our team. This internship opportunity provides a unique learning experience in the dynamic fields of Quality Assurance (QA) and Regulatory Affairs (RA) within the In Vitro Diagnostic Regulation (IVDR) landscape.
In this role, you will assist with various QA and RA activities to support the development, testing, and regulatory submission of IVD devices. This internship will provide you with hands-on experience to regulatory compliance, documentation, auditing, and quality management systems (QMS) in the medical device industry.
Key Responsibilities:
Quality Assurance (QA) Support:
Assist with the management and review of quality documentation (e.g., procedures, protocols, reports) to ensure compliance with IVDR, ISO 9001 and ISO 13485 requirements.
Support the preparation and coordination of internal and external audits, including organizing documents and tracking corrective actions.
Help in reviewing and approving product specifications and verification activities to ensure regulatory compliance.
Participate in risk management and product lifecycle management activities for IVD products.
Regulatory Affairs (RA) Support:
Assist in preparing and maintaining regulatory filings and technical documentation for IVDR products, ensuring they align with European Union and other global regulatory requirements.
Support the compilation of regulatory submissions, including device classification, labeling, and risk analysis.
Stay updated on changes to the IVDR and other related regulatory frameworks, and assist in implementing necessary updates in documentation and processes.
Cross-functional Collaboration:
Work closely with the RD team to ensure quality and regulatory requirements are met throughout the product lifecycle.
Participate in cross-functional team meetings to ensure timely completion of QA and RA deliverables.
Qualifications:
Currently pursuing or recently graduated with a degree in Pharmacy, Biology, Biotechnology, Life Sciences or a degree in a related field.
Strong interest in regulatory affairs, quality assurance, and the medical device industry, particularly in IVD.
Knowledge of the In Vitro Diagnostic Regulation (IVDR) and relevant medical device standards is a plus.
Strong attention to detail, problem-solving skills, and ability to work independently.
Excellent communication skills, both written and spoken.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
Ability to prioritize and manage multiple tasks in a fast-paced environment.
Good knowledge of English language both written and spoken.Contract type and period:
6 months on site paid stage.How to Apply:
Please submit your resume and cover letter to silvia.borrelli@chema.com.