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Job Title:  Regulatory Operations Specialist

Req ID:  24099
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.

Overview

Are you a recent/upcoming grad that’s looking to start your career or take the next step with a successful organization?  

 

As a Regulatory Operations Specialist, you will work to standardize and optimize regulatory activities in support of STERIS’s global business plan.  This is a cross-functional role where you will interact with other Regulatory professionals, product acquisition or development teams and the Quality group in achieving your objectives.  This department values analytical and critical thinkers who can multi-task in a fast-paced setting.

 

If you enjoy working in a dynamic environment, are passionate about the details, and enjoy collaborating with others to help positively affect business outcomes, this is the role for you!

What You Will Do

Establishment Registration and Device Listing
•    
Responsible for completing FDA’s annual facility establishment registration renewal according to FDA’s most current instruction and as determined to be appropriate with guidance from senior Regulatory staff. 
•    
Responsible for correctly evaluating and updating the device listings for medical devices processed at our Applied Sterilization Technology (AST) facilities as required in a timely manner, and as applicable to each registered facility. 
Drug Establishment Registration and Drug Listing
•    
Responsible for completing FDA’s biannual drug facility establishment registration renewal according to FDA’s most current instruction and as determined to be appropriate with guidance from senior Regulatory staff. 
•    
Responsible for correctly evaluating and submitting drug listings for drugs processed at our AST sterilization facilities as required in a timely manner, and as applicable to each registered facility. 
Tissue, Blood and Food Establishment Registrations
•    
Responsible for completing FDA’s annual registration for each AST facility that processes Human cells, tissues, or cellular or tissue-based products (HCT/Ps).
•    
Responsible for completing FDA’s biennial registration for each AST facility that processes human and/or animal Food products.
FDA Submission Support
•    
Responsible for ensuring that necessary User Fees are paid and available as needed for planned registrations. 
•    Maintain paper and 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.
•    Monitor current projects and pending and planned submissions to track timelines, identify any unexpected delays, and
communicate progress on projects and submissions to business partners.

What You Need To Be Successful

  • Bachelor's Degree required, preferably with scientific, engineering, regulatory, internal audit, quality systems, legal or general business core concentration
  • No specific work experience is required as this is an entry-level position
  • Self-starter that is highly organized.  
  • Strong oral and written communication skills.
  • Ability to balance multiple high priority responsibilities on-time and effectively.
  • Ability to perform assigned tasks in a highly complex environment.      
  • Excellent PC skills, including Microsoft Office applications.
  • Strong interpersonal skills

#LI-KW1

Offering You In Return

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

 

STERIS is a $3B, 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.

Req ID:  24099
Job Category:  Regulatory Affairs

Mentor, OH, US, 44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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