Mentor, OH, US, 44060
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.
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.
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.
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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STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers 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.
The full affirmative action program, absent the data metrics required by * 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location's HR Office during normal business hours.
Mentor, OH, US, 44060
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Nearest Major Market: Cleveland
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