Quality & Regulatory Compliance Specialist

Location

Mentor, OH | United States

Job 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

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. 

The 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.   

This position is based in Mentor, Ohio and requires time in the office. 

Duties

Product Corrections and Removals

• Responsible for assembling product and Customer data concerning product corrections, removals and field upgrades, tracking of Customer notifications and Field Service repairs, and maintenance of correction documentation.

Medical Device Reporting

• Responsible for investigating complaints for potential reporting under the FDA Medical Device Reporting regulations, preparing draft complaint summaries and MDR reports for presentation to the Reportable Events Committee for review and maintaining documentation in accordance with department policies, procedures, and work instructions.  

Internal Quality Audits

• Provide support to the Director, Quality & Regulatory Compliance in the development, enhancement, standardization, execution and implementation of processes to manage the 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 at global facilities as requested.  

Observation Follow-up

• Provide support to the Quality & Regulatory Compliance team in the investigation and resolution of global CAPAs.
• At the direction of the Director, Quality and Regulatory Compliance, 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.

Duties Continued

The Quality & Regulatory Compliance Specialist will develop a firm working knowledge of the following regulations and standards:

• 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
• 21 CFR Part 803 – Medical Device Reporting
• 21 CFR Part 806 – Medical Device 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
• EU MEDDEV 2 12-1: Guidelines on a Medical Device Vigilance System
• UK Medical Devices Regulations 2002

Required Experience / Education

• Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration.  
• No prior specific experience is required as this is an entry-level position.
• Excellent PC skills, including Microsoft Office applications.

• 10% domestic travel. Estimated to 5 weeks per year. International travel may also be 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 action; able to work effectively and professionally with external people including Customers and government officials.
• Ability to exercise judgment regarding which approaches are acceptable for meeting compliance requirements and to timely recognize and communicate significant compliance issues for resolution to Quality & Regulatory Compliance management.
• 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.

What we offer

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.    

#LI-SA2   #ZRSA-1 

Expectations

• Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
• Protect company confidential information by properly storing, retrieving, and disseminating such information only to those authorized.
• Perform data analysis/trending as requested.  
• Support continuous improvement efforts within the facility and the organization through participating in quality and performance improvement projects as requested.  
• Conduct daily activities of assigned job responsibilities and projects as assigned.
• Support a safe, clean, and secure working environment by supporting procedures, rules, and regulations.

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.

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Salary