Steris Corporation Mentor , OH 44060
Posted 1 week ago
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
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
Duties
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.
Duties - cont'd
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.
Education Degree
Required Experience
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
Posting
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
Skills
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.
Req ID: 44463
Job Category: Regulatory Affairs
Mentor, OH, US, 44060
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