Senior Regulatory Affairs Executive

A bit about us:

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.

Sigurðardóttir Iðnaður has an opening for a Senior Regulatory Affairs Executive. Our operations team supports drug products in clinical trials across the US, EU and Canada. You can work from home anywhere in Iceland. We have no office requirement.

Responsibilities:

• Assess design and manufacturing changes for regulatory impact and document the rationale
• File MDRs and support complaint and recall decisions with quality
• Review labeling, IFUs and promotional materials for regulatory compliance and supported claims
• Write and compile Module 3 CMC sections in eCTD format
• Support EU MDR technical documentation and notified body reviews
• Maintain establishment registrations and device listings

What you'll need:

• 5-7 years of regulatory affairs experience in medical devices, pharma or biologics
• Clear technical writing and careful editing
• Able to travel up to 10 percent
• Familiarity with eCTD structure and submission publishing tools

Desirable:

• RAC certification from RAPS
• Master's degree or PharmD
• EU MDR or IVDR transition experience

Schedule: Monday to Friday, standard business hours

What you get:

Rate: ISK 980,000 - ISK 1,150,000 per month

• Training budget

We may close the role early, so do not wait too long to apply.

Shortlisted candidates will hear from us within two weeks.

Duration: 12 months. Start: Immediately.

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