Job Title:  Regulatory Operations Specialist

Position Summary

The mission of the STERIS Regulatory Operations function is to standardize and optimize regulatory activities in support of STERIS’s global business plans. This includes: identification and management of global labelling and UDI requirements; determining registration and listing requirements in the US and working with STERIS facilities, customers, and suppliers to comply with these requirements; supporting traffic partners and regulators to resolve import/export issues; working with STERIS International Regulatory staff to identify requirements in other targeted markets; working with product acquisition and development teams to ensure regulatory requirements are met; and administering assigned corporate compliance activities such as document control, record retention, translation services and other processes as identified.

The Regulatory Operations Specialist must have a working knowledge of the following regulations guidance documents, and standards: 

•    21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
•    21 CFR Part 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers 
      of Devices
•    21 CFR Part 11 – Electronic Records, Electronic Signatures
•    ISO 13485 Medical devices – Quality management systems
•    EU Commission Medical Device Directive 1993/42/EEC (MDD) as amended by 2007/47/EC

These activities require close work with STERIS corporate domestic and international staff. The Regulatory Operations Specialist will have responsibility, when assigned, for performing the duties of the functional areas described below under the guidance and direction of his/her manager and other Regulatory Operations staff.
 

This is position is based in the Mentor, OH office. Eligible for a hybrid schedule. In office Monday, Wednesday & Thursday and remote Tuesday & Friday. 

Duties

The Regulatory Operations Specialist will focus on supporting STERIS businesses with an emphasis on STERIS Quality Management System, FDA registrations, document control, product registrations (FMR/JPAL), iProcurement, audits, customer support, and regulatory guidance.

• Responsible for correctly evaluating and updating the FDA’s medical device, drug, food, and tissue listings as required in a timely manner, and as applicable to each registered facility.
• Maintains paper and electronic submission documents, shared drive folders, portals, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
• Maintains STERIS Quality Management System policies, procedures and work instructions following STERIS document control processes and communicates and posts approved documents.
• Leads the Document Control Process which includes; ensuring timely and effective communications are sent to all internal stakeholders regarding periodic reviews and all phases of the Doc Control Process ensuring all items are actioned to meet required and assigned dates. Educates and guides stakeholders through the Doc Control Process. 
• Effectively facilitates meetings with internal stakeholders holding authors and stakeholders accountable. Communicates all priority items related to audits and ensures timelines are established. 
• Report regularly to management concerning project status, identifying and taking action on any unexpected changes, delays, or risk areas.
   

Duties - cont'd

• Conduct daily and weekly tasks of assigned job responsibilities and projects as assigned.
• Assists in the creation and updates of standard work and checklists for use to ensure completion of job responsibilities and project requirements.
• Responsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to his/her job functions.
• Assist in regulatory and compliance projects as needed.
• Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized while supporting a safe and secure work environment in alignment with STERIS procedures, and regulatory rules and regulations.
• Maintain conduct in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
   

Required Experience

• Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration
• 0-5 years in regulatory or quality preferably in medical device and or pharmaceutical
• Excellent PC skills, including Microsoft Office applications.
• Experience working on cross-functional teams.
• Previous experience leading/overseeing or project management.
   

What we offer

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.    

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Competencies