Regulatory Affairs Executive

Quality, regulatory and pharmacovigilance groups work across every site.

Job summary:

The previous person in this role moved to another team. The Regulatory Affairs Executive works with R&D, quality and clinical to build regulatory strategy and keep products compliant after launch. Remote position. Most of the team is in Warsaw, but nobody is required to come in. We use Slack, Notion and Google Meet. Cameras on for team calls.

Duties:

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

Required qualifications:

• 3+ years of regulatory affairs experience in medical devices, pharma or biologics
• Knowledge of ISO 13485 and ISO 14971 for device roles
• Familiarity with eCTD structure and submission publishing tools
• Able to travel up to 10 percent

Schedule: Monday to Friday, standard business hours

Salary: PLN 11,500 to PLN 16,000 per month

Perks and benefits:

• Private medical care
• Extra annual leave days
• Cafeteria benefit system
• Meal vouchers

We will only contact shortlisted applicants.

Start: Flexible.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Thicketbridge Bio sp. z o.o..