RA Engineer

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