Job Abstract

POSITION ANNOUNCEMENT

Name of Employer:        STERIS Corporation    
Position Title:            Senior Regulatory Affairs Specialist
Job Location:            5960 Heisley Road, Mentor, OH 44060 
(100% Telecommuting role. Reports to company headquarters in Mentor, OH. Can work remotely or telecommute)
Salary:                $101,908.04 to $122,000.00 /year
Hours:                Monday – Friday, 9:00 am to 5:00 pm
 

Summary of Duties:

•    Attend team meetings.
•    Document regulatory classification and regulatory requirements.
•    Guide teams through design controls and risk management
•    Prepare US regulatory submissions
•    Liaise with International regulatory and the labeling group on markets and timelines.
•    Review all proposed labeling and design documentation.
•    This person is the primary regulatory liaison to assigned manufacturing facilities.
•    Be responsible to review change requests and communicate any potential concerns with International regulatory and Compliance as necessary
•    Provide regulatory input for management review; participate in production/post-production analyses
•    Support the facility through regulatory audits and inspections
•    Review special sales requests
•    Review documents as part of internal review processes
•    Support the registration and listing process as requested.
•    Command of the specific guidance, standards, and regulations applicable to a particular product type or technology.
•    These activities require close work with STERIS corporate domestic and international staff and will include interactions with FDA as assigned.
•    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 senior Regulatory Affairs staff.
•    Assists senior Regulatory Affairs staff as assigned in writing, formatting, researching, compiling, reviewing, cross-checking, eCopying, submitting, and generating appropriate responses to FDA requests relating to premarket notifications. With experience, may be called on to author submissions, key sections, or response documents.
•    Maintains electronic submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
 

•    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.
•    Responsible for ensuring that 510(k) or other necessary User Fees are paid and available 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 Product Development and Continuing Support
•    Gathers information and documentation on proposed, newly acquired, or modified products to correctly determine product classification and submission and FDA listing
•    requirements.
•    When serving as Regulatory advisor on product development team, acts as champion for compliance with design controls, good documentation practices, and risk management standards.
•    Reviews documents carefully to ensure that user needs are clearly identified and required testing is planned to support the indications for use desired.
•    Synthesizes and actively supports STERIS Regulatory Affairs management’s Regulatory Strategy and accurately communicates it to business partners throughout the project. Engages Regulatory management as necessary when changes occur or new risks or requirements are identified, and proposes actions as appropriate.
•    Generates checklists for product development team use to ensure completion of requirements.
 

Qualifications:    
Master’s Degree in Regulatory Affairs, Engineering (any), or a related field of study AND two (2) years of work experience in the job offered or related occupation in which the required experiences was gained. In lieu of a Master’s Degree in Regulatory Affairs, Engineering (any), or a related field of study AND two (2) years of work experience in the job offered or related occupation in which the required experiences was gained, the employer will also accept a Bachelor’s degree in Regulatory Affairs, Engineering (any), or a related field of study and five (5) years of work experience in the job offered or related occupation in which the required experience was gained.

Must also have demonstrated experience with: Medical device and pharmaceutical regulations, product classifications, and applicable medical device or drug registration requirements for US and EU; International medical device or drug registration requirements; Authoring Regulatory Submissions - 510(k), Technical File, Master Files and Technical Dossier; Regulatory Strategy and Regulatory intelligence with effective interpretation of applicable US and EU guidance and ISO standards; Directing interactions and negotiations with regulators and agencies like FDA and Notified Body; Regulatory compliance, CE Marking and audits; Labeling, advertisement and promotional material review and approval; and Product development and lifecycle management in the Global regulatory environment.
 

To Apply:
    To apply, mail resume to: STERIS, HR, 5960 Heisley Road, Mentor, OH 44060; or apply online at https://www.careers.steris.com/; or visit  https://ohiomeansjobs.ohio.gov/home. Must reference Job Title & Code: 000095.
                        
THIS NOTICE IS BEING POSTED IN CONNECTION WITH THE FILING OF AN APPLICATION FOR PERMANENT ALIEN LABOR CERTIFICATION.  ALL APPLICANTS SHOULD REPORT DIRECTLY TO THE EMPLOYER.  ANY PERSON MAY PROVIDE DOCUMENTARY EVIDENCE BEARING ON THE APPLICATION TO THE REGIONAL CERTIFYING OFFICER OF THE DEPARTMENT OF LABOR:  

U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210