Knowledge & Skills

• Experience with electronic document publishing standards/formats, electronic and global regulatory submission publishing standards/formats.
• Excellent knowledge of publishing tools, global submission validation tools, Document Management systems, Toolbox, electronic submission gateways, MS Word, Adobe Acrobat including creating PDF hyperlinks and other support software.
• Review and organize critical documents associated with 510(k) eSubmitter electronic submission template, MDR and regional regulatory submissions, seeking guidance when necessary. Ability to convert PDF documents into Optical Character Recognition (OCR) documents, technical reports and other product related documentation for acceptability for electronic regulatory submissions.
• Identify registration documentation deficiencies and work with colleagues to accomplish resolution in a timely manner.
• Interpret global regulations/guidelines associated with electronic submissions and assure regulatory compliance, minimizing costs and delays.
• Exercise good judgment within policy and regulations.
• Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.
• Acts independently on all routine issues, makes judgment and executes.

Experience

• Bachelor’s Degree preferred in life sciences or Computer Science related subject.
• 2-4 years of experience in medical device (or equivalent) electronic submissions to the FDA, Notified Body, Health Canada and other regulators around the world.
• Able to organize technical documentation in the required electronic format and apply analytical and logical reasonings.

Job Type: Contract
Pay: $35.00 - $38.00 per hour

Schedule:

• Day shift

Experience:

• Regulatory submissions: 2 years (Required)
• MDR: 2 years (Required)

Ability to Commute:

• Lake Forest, IL 60045 (Required)

Work Location: In perso

Please refer the Job description for details