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

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 a wide-variety of regulations and standards applicable to the business including, 21 CFR Part 820- Medical Device Quality System Regulations (QSR) and ISO 13485 Medical Devices – Quality Management Systems.

 

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.

What You'll Do as a Quality & Regulatory Compliance Specialist

• Responsible for assembling product and Customer data concerning product corrections and removals, tracking of Customer notifications and Field Service repairs, and maintenance of correction documentation.
• 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 notified body audit program.  Support includes coordination of facility audit scheduling and issue resolution.  
• Responsible for monitoring the Regulatory Compliance email inbox and incoming mail for new events and MDR correspondence from FDA, preparing the agenda and assembling the documentation of potential reportable events for review by the Reportable Events Committee; submitting electronic MDR reports to FDA.
• 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.  
• 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.

The Experience, Skills and Abilities Needed

Required:

• Bachelor's degree in scientific, pharmaceutical, health sciences, or other relevant majors preferred OR six (6) years of experience in a similar field/position in lieu of degree
• Ability to travel domestically approximately 20%
• Excellent PC skills, including Microsoft Office applications

 

Preferred:

• Previous experience in a corporate office environment
• Previous relevant internship experience in quality, compliance, audit, or regulatory

 

Other:

• 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.

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 P