Quality & Regulatory Compliance Specialist

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

This is an entry-level position.  The mission of the STERIS Quality & Regulatory Compliance function is to implement repeatable and sustainable processes to ensure ongoing compliance with domestic and international regulations and standards.  This includes evaluating the relevance to all STERIS facilities and products and implementing efficient and effective processes to ensure adherence to applicable regulations and standards.  

 

Compliance activities require close work with STERIS corporate domestic and international staff and Customers and U.S and foreign government agencies.  The Quality & Regulatory Compliance Specialist will have responsibility for performing the duties of the functional compliance areas described below under the guidance and direction of his/her manager and other senior Quality & Regulatory Compliance staff.    

Location

This is a hybrid role based in STERIS’ Corporate Offices in Mentor, Ohio. In order to support the business needs working a minimum of 3 days a week in the Mentor office is expected.

 

10% domestic travel. Estimated to 5 weeks per year. International travel may also be required.

What you'll do as a Quality & Regulatory Compliance Specialist

• Responsible for investigating and managing complaints for potential reporting under the FDA Medical Device Reporting regulations and applicable international regulations, preparing draft complaint summaries and MDR/Vigilance reports for presentation to the Reportable Events Committee for review, and maintaining documentation in accordance with department policies, procedures, and work instructions.  
• Provide support to Quality & Regulatory Compliance management in the development, enhancement, standardization, execution, and implementation of processes to manage the Approved/Notified Body audit program.  
• Support includes coordination of facility audit scheduling and issue resolution.  
• Support execution of the supplier quality program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests and as necessary, issue resolution.
• Participate in quality system audits and readiness activities at global facilities as requested.  
• Provide support to the Quality & Regulatory Compliance team in the investigation and resolution of global CAPAs.
• At the direction of Quality & Regulatory Compliance management, support FDA and other regulatory agency responses following receipt of formal observations.
• Track corrective action activities for external audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments.
• Support STERIS’s participation in the FDA’s Case for Quality program as requested.
• Provide support to the Quality Operations team in supporting key objectives, trending, and process improvement.

The Experience, Skills and Abilities Needed

Required:

• Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration.  
• Excellent PC skills, including Microsoft Office applications, and use of AI tools is required.
• This is an entry-level position.
• Must be willing to travel domestically & internationally.

Preferred:

•  1+ years business experience
• Experience with risk management is helpful but not required.
• Bilingual skills are a plus, but not required.

Skills:

• Self-starter that is highly organized.  
• Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective actions; able to work effectively and professionally with external people including Customers and government officials.
• 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.

 

The Quality & Regulatory Compliance Specialist

will develop a firm working knowledge of regulations and standards applicable to the business including, but not limited to: 

•    21 CFR Part 820 – Quality Management System Regulation (QMSR)
•    21 CFR Part 803 – Medical Device Reporting
•    21 CFR Part 806 – Reports of Corrections and Removals
•    21 CFR Part 7 – Enforcement Policy, Subpart C – Recalls
•    21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
•    21 CFR Part 11 – Electronic Records, Electronic Signatures
•    ISO 13485 Medical devices – Quality management systems
•    ISO 9001 Quality management systems – Requirements
•    EN ISO 11135-1 Sterilization of healthcare products – Ethylene Oxide
•    EN ISO 11137-1 Sterilization of healthcare products – Radiation
•    ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
•    ISO 14971 Application of Risk Management to Medical Devices
•    EU Medical Device Directive
•    EU Medical Device Regulation
•    UK Medical Devices Regulations 2002

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.

 

Here is a brief overview of what we offer: 

 

• Market Competitive Pay
• Extensive Paid Time Off and (9) added Holidays
• Excellent Healthcare, Dental and Vision Benefits
• Long/Short Term Disability Coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Tuition Reimbursement and continued education programs
• Excellent opportunities for advancement in a stable long-term care

 

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Pay range for this opportunity is $58,100 - $62,000. This position is eligible for bonus participation.

 

Minimum pay rates offered will comply with county/city minimums, if higher than range listed.  Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

 

STERIS offers a comprehensive and competitive benefits portfolio.  Click here for a complete list of benefits: STERIS Benefits

 

Open until position is filled.

 

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 and life sciences products and services around the globe. For more information, visit www.steris.com.

 

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 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.