Regulatory Operations Intern

Job Title: Regulatory Operations Intern

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 And TEAM 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., U.K and EU 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
•    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
•    Utilize Excel and Powerpoint to prepare and present progress reports

Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies
 

Required Experience

Education Requirements
Currently enrolled in college with a major in science, engineering, regulatory, internal audit, premed, legal, or general business core concentration.

Experience, Knowledge or Skills
•    Proficient in Microsoft Word applications, including Word, Excel, PowerPoint and Outlook
•    The following competencies are critical for this position
o    Strong learning agility 
o    High energy
o    Resourceful
o    Team oriented 
o    Excellent communication skills (written and verbal)
o    Analytical thinker
o    Well-organized
o    Attention to detail and quality