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Title:  Corporate Regulatory Intern

Req ID:  14103
Category:  Regulatory Affairs
City:  Mentor
State:  OH
Postal Code:  44060
Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Corporate Regulatory Department is looking for energetic, dynamic and team oriented individuals to complement our group’s mission to diligently execute critical compliance initiatives. This dynamic role will provide exposure to many of the regulations, standards, and practices that define the regulatory landscape and govern the medical device industry, which may include yet not be limited to:  

  • 21 CFR Part 820 – FDA’s Medical Device Quality System Regulations (QSR)
  • 21 CFR Part 11 – Electronic Records, Electronic Signatures
  • 21 CFR Part 830 – Unique Device Identification
  • Global Unique Device Identification Database (GUDID) Guidance for Industry
  • FDA Premarket Notification 510(k)
  • FDA Establishment Registration and Device Listing
  • FDA’s Medical Device Databases
  • European Council Directive 93/42/EEC for medical devices
  • European Medical Device Regulation (MDR)
  • ISO 13485:2016 Medical devices – Quality management systems
  • ISO 9001:2015 Quality management systems

Duties

The intern is expected to learn and carry out tasks as assigned that will:

  • Support the maintenance and enhancement of Corporate Regulatory policies and procedures
  • Assist in collecting and organizing information on Regulatory SharePoint sites as needed
  • Assist with the collection of labels and product information needed for the submission of UDI information to the FDA and Global Data Synchronization Network (GDSN) for compliance with U.S. and U.K. UDI requirements.
  • Assist senior Regulatory Affairs staff as assigned in writing, formatting, researching, compilation, cross-checking, eCopying, submitting, and generating appropriate responses to FDA requests relating to premarket notifications
  • Assist with the dissemination of supplier notifications for UDI, collection of responses and maintenance of documentation
  • Maintain department records of medical device assessments and regulatory submissions
  • Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized
  • Conduct daily activities of assigned job responsibilities and projects as assigned
  • Support a safe, clean and secure working environment by supporting procedures, rules and regulations
  • Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies

Education Degree

  • High School Diploma or GED

Required Experience

  • Currently enrolled in college with a major in science, engineering, regulatory, internal audit, premedical, legal, or general business core concentration.
  • Proficient in Microsoft Word applications, including Word, Excel, PowerPoint and Outlook
  • The following competencies are critical for this position
    • Strong learning agility
    • High energy
    • Resourcefulness
    • Team oriented
    • Communication skills (written and verbal)
    • Analytical thinking
    • Organization and critical thinking skills

#monsterSTE

 

STERIS is a $2B+, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

Req ID:  14103
Category:  Regulatory Affairs
City:  Mentor
State:  OH
Postal Code:  44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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