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Job Title:  Regulatory Affairs Specialist

Req ID:  16548
Job Category:  Regulatory Affairs
Country:  US
State:  OH
City:  Mentor
Zip:  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 Regulatory Affairs Specialist serves as the primary regulatory liaison for new product development project teams. As such this person is responsible to 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; and review all proposed labeling and design documentation.

 

This person is the primary regulatory liaison to assigned manufacturing facilities. As such this person is 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; and support the registration and listing process as requested.

 

In addition, the Regulatory Affairs Specialist is expected to have good 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. The Regulatory Affairs 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 senior Regulatory Affairs staff.

Duties

510(k) Submission Support

  1. 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.
  2. 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.
  3. 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.
  4. Responsible for ensuring that 510(k) or other necessary User Fees are paid and available as needed for any planned submissions.
  5. 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

  1. Gathers information and documentation on proposed, newly acquired, or modified products to correctly determine product classification and submission and FDA listing requirements.
  2. 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.
  3. 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.
  4. Generates checklists for product development team use to ensure completion of requirements.
Education Degree
  • Bachelor's Degree in Engineering General or Business
Required Experience
  1. Four (4) year degree required, preferably with scientific, engineering or regulatory. 
  2. Professional certifications and regulatory, quality systems, or internal audit training certificates in relevant disciplines are desirable, although no particular certification is required.
  3. Minimum of 1 - 2 years professional experience, preferably 2 or more years including regulatory, governmental compliance matters, quality systems, internal auditing, applicable scientific or technical functions and/or healthcare industry experience.
  4. Self-starter with demonstrated organizational, project management, time management and problem-solving skills is preferred. Ideally, has experience working effectively on cross-functional teams.
  5. Demonstrated ability to balance multiple high priority responsibilities on-time and effectively.
  6. Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
  7. Strong oral and written communication skills.
  8. Excellent PC skills, including Microsoft Office applications.

 

STERIS is a $2B+, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates 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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