Senior Regulatory Affairs Executive

Our pipeline includes more than 30 programs in oncology, immunology and neuroscience. Clinical trials run at hundreds of sites, managed by our clinical operations group and CRO partners.

About the role:

Ingleby Therapeutics is hiring a Senior Regulatory Affairs Executive to support 510(k) and De Novo submissions for our cardiovascular device portfolio. Our Regulatory Operations team supports drug products in clinical trials across the US, EU and Canada. We are headquartered in Las Cruces and have been hiring remotely since 2020. You will join as an independent contractor on a long-term agreement. Payment is monthly in USD. Core hours overlap with US Central time, 9:00 AM to 1:00 PM CT. We ship you a laptop and accessories before your first day.

Main duties:

• Assess design and manufacturing changes for regulatory impact and document the rationale.
• Track submission timelines and commitments in Veeva Vault RIM or a similar system.
• Maintain establishment registrations and device listings.
• Monitor new guidance documents and summarise changes for the business.
• Keep regulatory files and correspondence organised and inspection ready.
• File MDRs and support complaint and recall decisions with quality.
• Review labeling, IFUs and promotional materials for regulatory compliance and supported claims.
• Build regulatory strategy memos for new products and line extensions.

Required qualifications:

• 6+ years of regulatory affairs experience in medical devices, pharma or biologics.
• Bachelor's degree in a life science, engineering or pharmacy.
• Able to travel up to 10 percent.
• Knowledge of ISO 13485 and ISO 14971 for device roles.

Nice to have:

• RAC certification from RAPS.
• Master's degree or PharmD.

Schedule: Monday to Friday, standard business hours

Compensation: $140,000 - $188,000 per annum

Benefits:

• Company laptop.
• Annual rate review.
• Paid time off.
• Monthly payments via wire transfer or Wise.

You must have full working rights in Australia.

Duration: 12 months. Start: Immediately.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Ingleby Therapeutics.