Regulatory Affairs Specialist (Remote)

Clinical trials run at hundreds of sites, managed by our clinical operations group and CRO partners. Since 1980, the company has built manufacturing sites in Queensland and abroad.

Position summary:

Jackson Biologics is hiring a Regulatory Affairs Specialist (Remote) to support 510(k) and De Novo submissions for our cardiovascular device portfolio.

Job duties:

• Support EU MDR technical documentation and notified body reviews.
• Track submission timelines and commitments in Veeva Vault RIM or a similar system.
• Assess design and manufacturing changes for regulatory impact and document the rationale.
• File MDRs and support complaint and recall decisions with quality.
• Write and compile Module 3 CMC sections in eCTD format.

What you need:

• 3-5 years of regulatory affairs experience in medical devices, pharma or biologics.
• Bachelor's degree in a life science, engineering or pharmacy.
• Comfortable managing several submissions and deadlines at once.
• Clear technical writing and careful editing.
• Able to travel up to 10 percent.
• Familiarity with eCTD structure and submission publishing tools.
• Knowledge of ISO 13485 and ISO 14971 for device roles.

Preferred:

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

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

What we offer:

• Annual salary review.
• Company laptop.
• Paid sick days.
• Two weeks of paid leave at year end.
• Health insurance through our employer-of-record partner.

Candidates must be eligible to work in United Arab Emirates.

Start: Immediately.

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