IVD Documentation & Regulatory Specialist

Tempus; Chicago (IL); On-site; USD 50,000 - 55,000; Full time

Benefits offered by this job

Benefits package

Stock options

Incentive compensation

Job summary

Tempus is seeking a documentation specialist for IVD projects to generate design documents, reports and SOPs supporting regulatory submissions. You will collaborate with Technical and Development Scientists, as well as Quality and Regulatory professionals, applying your experience in quality documentation in a medical device context.

The role requires on-site presence three days a week at our Chicago office and involves preparing validated documentation, maintaining filing systems, and

Qualifications

• Bachelor’s degree plus 2+ years of documentation experience in the medical device industry
• Organized and detail oriented
• Excellent written and verbal skills
• Ability to work well with cross functional teams
• Team driven
• Experience in a lab setting in life sciences and understanding of molecular biology and associated techniques
• Familiarity with a range of QMS systems and regulatory submissions
• Familiarity with ISO 13485 and FDA QSMR #LI-DA1

Responsibilities

• Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing
• Draft and edit quality system compliant documentation such as SOPs, batch records, and work instructions for lab-related processes
• Track batch records and checklists produced during IVD clinical validations and ensure compliance
• Maintain appropriate filing systems
• Documentation review for consistency and compliance
• Help oversee implementation of new documentation and version control
• Serve as a point of contact for documentation retrieval
• Aid in preparation for internal and external audits
• Manage multiple sources of information for documentation purposes
• Help to continuously improve IVD and LDT development documentation and processes

Skills

Organization

Written/verbal communication

Cross-functional teamwork

Team oriented

Lab experience (life sciences)

Fast-paced environment

QMS familiarity

Regulatory submissions

Education

Bachelor’s degree

Job description

Tempus is seeking a documentation specialist for IVD projects to generate design documents, reports and SOPs supporting regulatory submissions. You will collaborate with Technical and Development Scientists, as well as Quality and Regulatory professionals, applying your experience in quality documentation in a medical device context.

The role requires on-site presence three days a week at our Chicago office and involves preparing validated documentation, maintaining filing systems, and