What are the responsibilities and job description for the Regulatory Documentation Specialist/QA Documentation Specialist (EUMDR/Medical Device) position at Systems Ally?
This is an onsite role.
Update on what the HM is looking for:
- Level of education required/preferred - bachelor’s in science field
- This role is more focused on EU IVDR
- What types of regulator documents will be supported - These will be EU IVDR submissions
- They will author documents, verify work of others and proofread their own work
- Software that is required- Word, Excel.
Duties
- Prepares technical documents to support both domestic and international regulatory submissions.
- Incorporates text, graphs, charts, tables and statistical analysis.
- Proofreads, circulates, edits, assembles, inspects and duplicates product submissions.
- 3-5 years exp.
Job Type: Contract
Pay: $44.00 - $46.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- Bachelor's (Preferred)
Experience:
- Regulatory submission documentation: 3 years (Preferred)
- EUMDR: 3 years (Preferred)
- medical device industry: 3 years (Preferred)
- Quality documentation: 3 years (Preferred)
Ability to Commute:
- Des Plaines, IL 60016 (Preferred)
Work Location: In person
Salary : $44 - $46
