Regulatory Operations Specialist in Mentor, Ohio

Job Title:
Regulatory Operations Specialist
Req ID:
43561
Job Category:
Regulatory Affairs
Mentor, OH, US, 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 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 d