Join Steris as Regulatory Operations Specialist in Mentor Ohio. At the Steris you will perform tasks as listed below, Apply Steris Regulatory Affairs careers in Mentor OH.
Position : Regulatory Operations Specialist
Job Category: Regulatory Affairs
Work location : Mentor, Ohio
Job Segment : Medical Device, Operations Manager, Document Control, Quality Manager, Facilities, Healthcare, Operations, Administrative, Quality
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 labeling and UDI requirements; data management, 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 will develop a firm working knowledge of the following regulations and standards:
• ISO 13485 Medical devices – Quality management systems
• 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 801 – Medical Device Labeling
• Global Unique Device Identification Database (GUDID) Guidance for Industry
The Regulatory Operations Specialist will have responsibility for performing the duties of the functional areas described below, as assigned, under the guidance and direction of his/her manager and other senior Regulatory Operations staff.
What You’ll Do
Establishment Registration and Device Listing
• Responsible for completing FDA’s periodic facility establishment registration renewals according to FDA’s most current instruction and as determined to be appropriate with direction from senior Regulatory staff.
• Responsible for correctly evaluating and updating the device listings for medical devices as required in a timely manner, and as applicable to each registered facility.
• Assists senior Regulatory Operations staff as assigned in writing, formatting, researching, compiling, cross-checking, submitting, and generating appropriate Regulatory submissions (e.g., DMF/MAF, GUDID, EUDAMED, JPAL).
• Monitors current projects and pending and planned submissions to track timelines, identifies any unexpected delays, and communicates progress on projects and submissions to business partners.
• Maintains paper and electronic submission documents, shared drive folders, portals, and databases (e.g., CDER Direct, CBER, FURLS, SUS) in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information.
• As requested, processes User Fees as needed for any planned submissions.
• Handles any FOI requests to FDA, maintaining records of the communications and any payments made. Facilitates the completion of submission redaction requests received from the FOI office.
What You’ll Do – cont’d
Product Development, Document Control and Continuing Support
• Completes assigned document control activities for STERIS Quality Management System policies, procedures and work instructions following STERIS document control processes and communicates and posts approved documents.
• Gathers information and documentation on proposed, newly acquired, modified products and/or processed products to assist in product classification and submission and FDA listing requirements.
• Acts as champion for compliance with design controls, good documentation practices, and risk management standards. Reviews documents carefully to ensure that user and Customer needs are clearly identified and met.
• Supports STERIS Regulatory management’s identified strategy and accurately communicates it to business partners throughout assigned projects and processes. Engages Regulatory management as necessary when changes occur or new risks or requirements are identified.
• In the event that the Specialist serves as a Regulatory Representative, applies regulatory knowledge and judgment to identify potential compliance concerns and gathers and presents sufficient information to facilitate Regulatory management’s appraisal of any proposed changes or resolution of compliance issues.
• Responsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to his/her job functions.
• Maintain conduct in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
• 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.
Education That You Will Need To Succeed
Bachelor’s DegreeWhat You Need To Be Successful
1. Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, pre-medical, legal, or general business core concentration. Exception to degree requirement considered depending on combination of education, certifications and relevant regulatory experience.
2. Bilingual skills are a plus, but not required.
STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics. We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 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.
Nearest Major Market: Cleveland
Nearest Secondary Market: Akron
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