Regulatory Affairs Associate, Diagnostics

Quality, regulatory and pharmacovigilance groups work across every site.

Position summary:

Looking for a Regulatory Affairs Associate, Diagnostics who wants to stay somewhere for a while. This position focuses on CMC sections for IND amendments and an upcoming NDA. Fully remote. You can work from anywhere in Poland.

Key responsibilities:

• Build regulatory strategy memos for new products and line extensions
• 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
• Keep regulatory files and correspondence organised and inspection ready
• Write and compile Module 3 CMC sections in eCTD format
• Support EU MDR technical documentation and notified body reviews
• Track submission timelines and commitments in Veeva Vault RIM or a similar system

Required qualifications:

• 1-2 years of regulatory affairs experience in medical devices, pharma or biologics
• Able to travel up to 10 percent
• Clear technical writing and careful editing
• Knowledge of ISO 13485 and ISO 14971 for device roles
• Familiarity with eCTD structure and submission publishing tools
• Comfortable managing several submissions and deadlines at once

Preferred qualifications:

• Software as a medical device (SaMD) and cybersecurity submissions
• EU MDR or IVDR transition experience
• Experience with Veeva Vault RIM

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

PLN 9,600 - PLN 11,500 monthly

Perks and benefits:

• Remote work allowance

Let us know your current notice period and salary expectations.

Duration: 9 months. Start: Immediately.

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