Job Summary
A staffing company is filling a position for a Remote Regulatory Affairs Specialist in Pittsburgh.
Candidates will be responsible for the following:
- Creating classification documents according to new regulations
- Communicating identified gaps
- Reviewing and approving product labeling plans
Applicants must meet the following qualifications:
- Ability to travel onsite when necessary
- Bachelor's /Master's degree or equivalent
- Ability to support EUDAMED database data collection and uploads
- Ability to support QMS system updates for compliance with the EU MDR
- Ability to support internal and external quality audits, as needed
- Ability to provide regulatory training and guidance