Quality & Regulatory Compliance Intern - Fall 2026-Spring 2027

Required

• Currently enrolled in college with a major in Science, Engineering, Regulatory, Internal Audit, or general business core concentration.
• Sophomore year requirements must be completed before internship start.
• Proficient PC skills, including Microsoft Office applications.

What You'll Do as a Quality & Regulatory Compliance Intern

1. 1Develop knowledge of regulations and standards including, but not limited to:
   • 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
   • 21 CFR Part 803 – Medical Device Reporting
   • 21 CFR Part 806 – Medical Device Corrections and Removals
   • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
   • 21 CFR Part 11 – Electronic Records, Electronic Signatures
   • ISO 13485 Medical devices – Quality management systems
   • ISO 9001 Quality management systems – Requirements
   • EN ISO 11135-1 – Sterilization of healthcare products – Ethylene Oxide
   • EN ISO 11137-1 – Sterilization of healthcare products – Radiation
   • ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
   • EU Medical Device Regulation
2. 2Responsible for assembling product and Customer data concerning product corrections, removals, and field upgrades, tracking of Customer notifications and Field Service repairs, and maintenance of correction documentation.
3. 3Support execution of the supplier quality program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests and as necessary, issue resolution.
4. 4Provide support to the Quality & Regulatory Compliance team with investigation and resolution to audit findings.
5. 5Track corrective action activities for external audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments.
6. 6Perform data analysis/trending as requested.
7. 7Responsible for investigating and managing complaints for potential reporting under the FDA Medical Device Reporting regulations and applicable international regulations, preparing draft complaint summaries and MDR/Vigilance reports for presentation to the Reportable Events Committee for review, and maintaining documentation in accordance with department policies, procedures, and work instructions.