Quality & Regulatory Compliance Intern - Fall 2026-Spring 2027

We need to output HTML fragment with sections: About the role? The posting includes Position Summary, Key Program Info, What You'll Do, Required, Preferred, Other, Pay range, Benefits mention. We must not repeat job title as heading. Use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which sections have content. We have: - Position Summary: could be About the role. - Key Program Info: Dates, Location, Work Environment, Hours. Could be Schedule? Actually schedule is part-time 20 hrs minimum per week. Could be Schedule section. Also location maybe not needed as heading; we can embed in paragraph. - What You'll Do: Responsibilities. - Required: Requirements (maybe Qualifications). Could be Requirements. - Preferred: maybe Qualifications or Skills. - Other: Skills (self-starter etc.) - Pay range: Pay. - Benefits: Benefits. We should not create sections with placeholder text. We have actual content for each. We must not include boilerplate like EEO, accommodation contact, etc. Remove those. We must preserve all substantive information. We need to format lists with

• for any list of duties/requirements/benefits. We need to use

  for prose. We must not repeat job title as heading. We must not include Job ID/requisition numbers. We must output only HTML fragment. Let's craft:

  About the role

  Position Summary The STERIS Quality & Regulatory Compliance team is seeking a part-time intern to assist with a variety of projects on team. This role will provide a foundation for applying what has been learned in the classroom environment to practical hands-on application in a corporate environment. The Quality & Regulatory Compliance Intern will have exposure to domestic and international regulations and standards, business processes to ensure adherence to applicable regulations and standards, and collaboration with STERIS corporate domestic and international staff, Customers, Approved/Notified Bodies, and U.S and foreign government agencies.

  Key program information

  maybe not a standard heading; but we could use About the role already. Could combine. But we need headings only from list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to map content to those. We have schedule info: Hours: Part-time (20 hours minimum per week). Also Dates: Fall 2026 - Spring 2027 (potential to extend). Location: Mentor, OH. Work Environment: Onsite. We could put Schedule section with hours and maybe dates? But schedule heading is for schedule; we can include hours and maybe mention part-time. Could also include location in paragraph. We have Pay section: Pay range $21/hr. Benefits: STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits. Responsibilities: What You'll Do as a Quality & Regulatory Compliance Intern (list of duties). Requirements: Required The Experience, Skills and Abilities Needed (list). Could be Requirements. Qualifications: maybe Preferred GPA etc. Could be Qualifications. Skills: Other (self-starter etc.) could be Skills. We must not create sections with filler. All have content. Let's extract details. Responsibilities list: - Develop 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 - Responsible 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. - Support execution of the supplier quality program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests and as necessary, issue resolution. - Provide support to the Quality & Regulatory Compliance team with investigation and resolution to audit findings. - Track corrective action activities for external audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments. - Perform data analysis/trending as requested. - Responsible 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. That's a lot; we can keep as list. Requirements (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. Preferred: - Preferred GPA of 3.0 or above. Other (Skills): - Self-starter that is highly organized. - Strong interpersonal skills – ability to work closely with people at all levels within the organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials. - Ability to exercise judgment regarding which approaches are acceptable for meeting compliance requirements and to timely recognize and communicate significant compliance issues for resolution to Quality & Regulatory Compliance management. - Strong oral and written communication skills. - Ability to balance multiple high priority responsibilities on-time and effectively. - Ability to perform assigned tasks in a highly complex environment. Pay: - Pay range for this opportunity is $21/hr. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. Benefits: - STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits. Schedule: - Dates: Fall 2026 - Spring 2027 (potential to extend) - Location: Mentor, OH - Work Environment: Onsite - Hours: Part-time (20 hours minimum per week) We could combine schedule info in a paragraph or list. We must not include boilerplate like "Open until position is filled." etc. Also remove company description, contact info, EEO. We must preserve all substantive information; we removed some like "Open until position is filled." that's not substantive? It's about application timing; maybe considered boilerplate? It's not essential to role; but instruction says remove duplicated lines, cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. "Open until position is filled." is like application instruction; we can drop. Also "STERIS is a leading global provider..." etc is company description; could be considered boilerplate? It's not about role; but maybe we keep? The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Company description may not be required; but it's not explicitly prohibited. However to be safe, we could keep it as part of About the role? But it's not about role. Might be considered filler. I'd drop it. Also "If you need assistance completing the application process, please call..." drop. Now craft HTML. We need to use

  for each section heading. We'll have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Let's write. About the role: combine position summary and key program info? But we have separate schedule section; we could put location etc in About the role. But schedule section will have hours etc. Let's put About the role with position summary and maybe mention it's part-time intern. But schedule section will have hours etc; we can still include location and dates there. Let's do:

  About the role

  The STERIS Quality & Regulatory Compliance team is seeking a part-time intern to assist with a variety of projects on the team. This role will provide a foundation for applying classroom knowledge to practical hands‑on application in a corporate environment. The intern will gain exposure to domestic and international regulations and standards, business processes to ensure adherence, and collaboration with STERIS corporate domestic and international staff, customers, approved/notified bodies, and U.S. and foreign government agencies.

  Responsibilities

  • Develop 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
  • Responsible 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.
  • Support execution of the supplier quality program, including qualifications and/or audits, routine monitoring, assessment meetings, action requests and, as necessary, issue resolution.
  • Provide support to the Quality & Regulatory Compliance team with investigation and resolution to audit findings.
  • Track corrective action activities for external audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments.
  • Perform data analysis/trending as requested.
  • Responsible 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.

  Requirements

  • 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.

  Qualifications

  • Preferred GPA of 3.0 or above.

  Skills

  • Self‑starter that is highly organized.
  • Strong interpersonal skills – ability to work closely with people at all levels within the organization and facilitate the implementation of corrective action; able to