Regulatory Affairs Specialist III

Lab space is in an incubator building with shared equipment and a loading dock. We need a Regulatory Affairs Specialist III who can assemble submission-ready documents and work through FDA questions without hand-holding. Fully remote. You can work from anywhere in the US.

• Track submission timelines and commitments in Veeva Vault RIM or a similar system
• Prepare and submit 510(k)s, IND amendments, annual reports and other FDA filings
• Build regulatory strategy memos for new products and line extensions
• Write and compile Module 3 CMC sections in eCTD format
• Support EU MDR technical documentation and notified body reviews

Skills and experience

• 6+ years of regulatory affairs experience in medical devices, pharma or biologics
• Hands-on experience preparing at least one FDA submission

Schedule: Monday to Friday, standard business hours.

Salary range: $122,000 - $145,000 a year

We offer medical, dental and vision insurance, 401(k) with company match, paid sick leave, ceu reimbursement, dental insurance, license reimbursement and employee discount.

We are unable to sponsor visas for this position.

Start: Within 30 days.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Midland Life Sciences.