As a RA Specialist, you will support the QA&RA team in ensuring that our medical devices comply with international regulations. You will support the preparation and update of technical documentation, the submissions to Notified Bodies and Competent Authorities, and stay ahead of the evolving regulatory landscape in the EU (MDR) and US (FDA). Key Responsibilities Regulatory Intelligence : Monitor changes in international regulations (e.g. MDR), standards (e.g. ISO, ASTM), and guidance documents (e.g. MDCG, FDA guidances) that impact the company’s portfolio. Technical Documentation : Support the creation, update, and maintenance of Technical Files in compliance with EU MDR 2017/745. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Labelling & Instructions for Use : Support the review of labels, IFUs (Instructions for Use), and website content to ensure consistency with approved regulatory claims. Regulatory Database Management : Support the registration of products in EUDAMED and other international databases (e.g., GUDID for UDI). Post-Market Surveillance (PMS) : Collaborate in the drafting of PMS documents (e.g. PMS Plan, PMS Reports, PM Clinical Follow-up and Periodic Safety Update Reports) and assist in gathering PMS data. Certification bodies relationships : Collaborate to the management of the relationship with consultants, Notified Bodies and Competent Authorities regarding submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Clinical Affairs Interface : Support the Clinical Study Management team in managing adverse event reporting and field safety corrective actions (FSCA) and support the link between clinical evaluation reports (CER) and technical documentation to ensure consistency. Support Quality Management System maintenance : Collaborate to maintain and improve company Quality Management System (QMS) in compliance with ISO 13485, MDR and FDA 21 CFR Part 820. Required Skills & Qualifications Mandatory Requirements (Must Have) We are looking for self‑motivated individuals who are eager to learn and driven to build a career in Regulatory Affairs. Our team invests heavily in coaching new hires. Education : master’s degree in Engineering, Biotechnology, Biology, Pharmacy or related scientific field. A Master/Post‑graduate course in Regulatory Affairs is a plus. Experience : 0‑2 years of experience. We are open to brilliant fresh graduates who have written a thesis on regulatory/quality topics or have completed an internship in a regulated industry. Communication : professional fluency in English (written and spoken) and the ability to effectively collaborate with cross‑functional teams. IT : excellent knowledge of MS Office (Word and Excel). Soft skills : excellent organizational skills, goal‑oriented mindset, attention to details, attitude to teamwork and ability to work in a small, fast‑growing startup environment. Preferred Requirements (Nice to have) Previous experience within the area of Regulatory Affairs, preferably in the medical device industry. Previous experience with biodegradable implantable medical devices. Knowledge of FDA 21 CFR 820, EU MDR and GMP. Knowledge of risk management processes (ISO 14971). Previous experience with Asana software or other work management platforms. What We Offer Starting gross annual salary (RAL) of €26,000 under the Chemical Industry SME collective agreement (CCNL Chimico Confapi). The compensation package also includes: Annual company’s performance bonus of €2,300 gross. A €1,000 annual welfare allowance. €8 meal vouchers for each working day. Hybrid work policy with one day of remote work per week. Accident and supplementary health insurance coverage. In accordance with current regulations, this position is open to candidates of all genders, without any form of discrimination. #J-18808-Ljbffr