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Title:  Quality & Regulatory Compliance, Senior Associate

Req ID:  13374
Category:  Regulatory Affairs
City:  Mentor
State:  OH
Postal Code:  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 manage various projects related to implementation of repeatable and sustainable processes to ensure on-going 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 Project Manager must have strong 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 11 – Electronic Records, Electronic Signatures
  • 21 CFR Section 1271.150 – Current Good Tissue Practice (cGTP)
  • Health Canada, Food and Drug Regulations, Division 2, Part C: Good Manufacturing Practices – Drugs
  • ISO 13485: Medical devices – Quality management systems
  • ISO 9001: Quality management systems
  • EN ISO 11135-1:2007 – Sterilization of healthcare products – Ethylene oxide
  • EN ISO 11137-1:2006 – Sterilization of healthcare products - Radiation
  • ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories [Biotest Labs]
  • Medical Device Single Audit Program (MDSAP)

 

The compliance activities require close work with STERIS corporate domestic and international staff and Customers and U.S and foreign government agencies. 

Duties

  1. Direct all phases of assigned projects from inception through implementation and evaluation of the outcomes of the project to ensure alignment with the defined scope and goals of the project were achieved.
  2. The individual will organize and lead cross-functional core project teams as applicable on highly critical quality system and compliance work.  The projects managed by the Project Manager represent critical strategic compliance initiatives that are broad in scale and scope and have direct visibility to senior management.
  3. The Project Manager will ensure smooth implementation and transition of system and/or process changes across every facility in the AST division and/or applicable healthcare facilities.
  4. Strategically assess current systems and processes for identification of improvement opportunities and re-development.  
  5. Leads the development, enhancement and standardization of Quality & Regulatory Compliance processes and their implementation as policies and procedures; responsibilities include working with and developing strong relationships with key personnel in other critical areas of the organization to develop sound policies and procedures that can be universally applied.
  6. Provide support to management in the development, enhancement, standardization, execution and implementation of processes to manage the Medical Device Single Audit (MDSAP) and notified body audit programs.  Support includes coordination of facility audit scheduling and issue resolution. 
  7. The individual will also be expected to perform quality system audits of STERIS facilities at the direction of the Senior Vice President & Chief Compliance Officer and Senior Director, Quality and Regulatory Compliance.  Responsibilities also include implementation of systemic corrective actions from internal and external audits across all STERIS facilities as applicable. 
  8. Manages the evaluation, development, and implementation of a compliant electronic quality management system adequate for STERIS. 
  9. Willingness for accepting ownership for accomplishing new and different requests. 
  10. Provide support to Regulatory Affairs management as requested during the development of Senior Management and Compliance Committee presentation materials.
  11. Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
  12. Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
  13. Conduct daily activities of assigned job responsibilities and projects as assigned.
  14. Support a safe, clean and secure working environment by supporting procedures, rules and regulations.

Duties - cont'd

Education Degree

Bachelor's Degree

Required Experience

  1. Four (4) year degree required, preferably with scientific, engineering, regulatory or management core concentration.
  2. Minimum of 5 to 7 years professional experience in a regulated environment, preferably with regulatory affairs, legal or governmental compliance, quality systems, and/or healthcare industry experience.
  3. Completion of or actively working towards an advanced degree or professional certification in relevant disciplines are desirable.
  4. Project Management or Regulatory/Quality Certification.
  5. Bilingual skills are a plus, but not required.
  6. Self-starter with significant demonstrated organizational, project management, time management and problem-solving skills.   
  7. Significant experience coordinating cross functional teams.
  8. Can comfortably and effectively confront difficult situations and issues in a timely and appropriate manner.
  9. Demonstrated ability to balance multiple high priority responsibilities on-time and effectively.
  10. 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.
  11. Strong oral and written communication skills.
  12. Excellent PC skills, including Microsoft Office applications, and experience working with an electronic quality management system.

 

Working Conditions

Typical Office Setting

Travel up to 10%

 

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.

Req ID:  13374
Category:  Regulatory Affairs
City:  Mentor
State:  OH
Postal Code:  44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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