Graduate Regulatory Affairs Officer

About the company:

Lab space is in an incubator building with shared equipment and a loading dock. Sigurðardóttir Iðnaður is a seed-stage biotech with 15 scientists in shared lab space in Reykjavik. Friday afternoons are set aside for seminars and journal club.

Position summary:

Sigurðardóttir Iðnaður is hiring a Graduate Regulatory Affairs Officer 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.

What you'll be doing:

• File MDRs and support complaint and recall decisions with quality.
• Track submission timelines and commitments in Veeva Vault RIM or a similar system.
• Review labeling, IFUs and promotional materials for regulatory compliance and supported claims.
• Keep regulatory files and correspondence organised and inspection ready.
• Support EU MDR technical documentation and notified body reviews.
• Monitor new guidance documents and summarise changes for the business.
• Write and compile Module 3 CMC sections in eCTD format.
• Maintain establishment registrations and device listings.

You'll need:

• Bachelor's degree in a life science, engineering or pharmacy.
• Comfortable managing several submissions and deadlines at once.
• Knowledge of ISO 13485 and ISO 14971 for device roles.
• Familiarity with eCTD structure and submission publishing tools.

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

Compensation and benefits:

Salary: ISK 420,000 - ISK 490,000/month

• Occupational pension.
• Wellness allowance.
• Lunch benefit.
• Five weeks of annual leave.
• Training budget.
• Flexible working hours.

Candidates must be eligible to work in Iceland.

Start: Immediately.

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