Key Skills

Job Description

About us Cassini Technologies is a Dutch medical device company that develops and sells advanced ophthalmic diagnostic devices. Our products are on the market in the EU, the USA and a growing number of countries worldwide. About the role Our Regulatory Affairs team is growing, with new products, new markets and new digital tools. As Regulatory Affairs Engineer, you’ll own day-to-day regulatory activities, keep our products on the market internationally and help us enter new markets. You’ll work closely with experienced RA colleagues, distributors, authorities and teams across the company, and build your expertise along the way. What you’ll do International registrations Coordinate and maintain device registrations across international markets Prepare registration dossiers, manage submissions and respond to questions from authorities Act as the main RA contact for distributors and local regulatory agents Maintain registration documents such as certificates, declarations and letters of authorisation Keep manufacturer and device data up to date in EUDAMED, swissdamed and other national databases Regulatory operations and digital tools Help implement our new regulatory information management system (MedBoard), from data migration to ongoing maintenance Plan and track recurring activities such as renewals, periodic reports and technical documentation reviews Monitor regulatory changes in current and new markets and assess their impact Compliance and change management Coordinate change notifications to notified bodies and authorities Assess how product, labelling and supplier changes affect registrations Support technical documentation and post-market activities (PMS, PSUR, PMCF, vigilance) Support internal and external audits and follow up on actions Review marketing and product information for regulatory consistency What you bring A degree in biomedical engineering, life sciences or a related field, or equivalent experience At least 2 years of regulatory affairs experience in medical devices, ideally active devices Hands-on experience with registrations, submissions or market access Experience working with distributors, regulatory representatives or authorities Working knowledge of EU MDR (2017/745), ISO 13485 and ISO 14971 Excellent written and spoken English Nice to have FDA experience (establishment registration, device listing, 510(k)) Registration experience in Canada, India or other markets outside the EU and USA Experience with EUDAMED, swissdamed or similar databases Experience with PMS, PSUR, PMCF or vigilance Familiarity with IEC 60601-1, IEC 62304 or IEC 62366-1 Experience with ophthalmic or diagnostic devices RA training or certification (e.g. RAC, TOPRA) Other languages How you work You take ownership and see things through You’re structured and precise, and keep records accurate and traceable You raise issues early and communicate clearly You manage several deadlines on your own You’re comfortable with digital tools and keen to keep learning What we offer A hands-on role with real responsibility and room to grow The chance to shape our digital regulatory tools and processes A collaborative, international team in a growing company Hybrid working 25 days of annual leave Pension contribution

Core Responsibilities

Coordinate and maintain international medical device registrations, prepare submissions, respond to regulatory authorities, and keep registration records and database information current. Support regulatory systems and recurring compliance activities, assess the impact of product and supplier changes, and contribute to technical documentation, post-market activities, audits, and review of product and marketing information.

Requirements

A degree in biomedical engineering, life sciences, or a related field, or equivalent experience, and at least two years of medical device regulatory affairs experience are required. Candidates should have hands-on registration or market-access experience, working knowledge of EU MDR, ISO 13485, and ISO 14971, and excellent written and spoken English.

Benefits

• Annual Leave
• Pension Contribution