Share this Job

Job Title:  Quality & Regulatory Compliance Specialist

Req ID:  29800
Job Category:  Government 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.

Position Summary

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

What You Will Learn

  • 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

What You Will Learn - cont'd

  • 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

#LI-MM1 #ZRMM

Required Experience

  • Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration. 

Preferred Experience

  • 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.      
  • Excellent PC skills, including Microsoft Office applications.

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 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:  29800
Job Category:  Government Affairs

Mentor, OH, US, 44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

Job Segment: Medical Device, Quality Manager, Internal Audit, Inspector, Engineer, Healthcare, Quality, Finance, Engineering