Regulatory Affairs Specialist I

Lab space is in an incubator building with shared equipment and a loading dock. Sigurðardóttir Iðnaður is hiring a Regulatory Affairs Specialist I to support 510(k) and De Novo submissions for our cardiovascular device portfolio. Remote position. Most of the team is in Reykjavik, but nobody is required to come in. You will need a reliable internet connection and a quiet place to work.

• Monitor new guidance documents and summarise changes for the business.
• Build regulatory strategy memos for new products and line extensions.
• Review labeling, IFUs and promotional materials for regulatory compliance and supported claims.
• Support EU MDR technical documentation and notified body reviews.
• Coordinate with international distributors on country registrations.

Skills and experience:

• 1+ years of regulatory affairs experience in medical devices, pharma or biologics.
• Familiarity with eCTD structure and submission publishing tools.
• Comfortable managing several submissions and deadlines at once.
• Knowledge of ISO 13485 and ISO 14971 for device roles.

Schedule: Remote within US time zones, with quarterly travel to headquarters.

We offer flexible working hours, training budget, five weeks of annual leave, wellness allowance, lunch benefit and occupational pension.

Let us know your current notice period and salary expectations.

Start: Immediately.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Sigurðardóttir Iðnaður ehf..