Responsibilities :
- Prepare / review international submissions and technical files.
- Evaluate changes to manufacturing processes and product design against FDA and international requirements and provide guidance to engineering and manufacturing teams.
- Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities.
- Ensure compliance with company policies, procedures and applicable regulations and standards worldwide.
- Help RA Director with assigned projects / submissions.
The project can be completed while working remotely.
This consultant will work on international registrations and sustaining activities including but not limited to review of Change Orders, NCMR, Process Deviations, Technical File updates, and EU MDR remediation.
Education and Experience :
- years of Medical Device industry experience
- BS degree minimum
- Experience with Class III devices or Class IIb implants
- Prior experience supporting EU MDR remediation projects
- Must be able to work independently with minimal direction / instruction
- Strong communication skills, especially while working remotely
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