Regulatory Affairs & Quality 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 Regulatory Affairs & Quality 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.

This position is a fully remote role.

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 – Medical Device Quality System Regulations (QSR)
• 21 CFR Part 11 – Electronic Records, Electronic Signatures
• ISO 13485 Medical devices – Quality management systems
• EU Medical Device Regulation 2017/745

The regulatory and 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.

Duties

• 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.
• 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.
• Develop, analyze, and maintain trend reporting for facility QMS data to heighten awareness and drive action for relevant leadership.
• Completes assigned document control activities for STERIS Quality Management System policies, procedures, and work instructions, including the review and approval of associated promotional material, following STERIS document control processes and communicates and posts approved documents.
• Review, analyze and action new and revised regulatory standards as an input into the QMS including Management Review, technical documentation and/or design history files (where applicable).
• Gathers information and documentation on proposed, newly acquired, modified products and/or processed products to assist in product classification, submission, and approval to support continued, compliance business.
• Supports STERIS Regulatory management’s identified strategy and accurately communicates it to business partners throughout assigned projects and processes. Engages Regulatory management as necessary when changes occur, or new risks or requirements are identified.
• Generating and maintaining technical documentation and/or design history files.
• Applies regulatory knowledge and judgment to identify potential compliance concerns and gathers and presents sufficient information to facilitate Regulatory management’s appraisal of any proposed changes or resolution of compliance issues.
• Monitors current projects and pending and planned submissions to track timelines, identifies any unexpected delays, and communicates progress on projects and submissions to business partners.

Required Experience

• Bachelor's degree, six years' experience in similar field/position will be accepted in lieu of a Bachelor's degree.
• 0-3 years' experience.
• 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.
• Must be comfortable with up to 10% travel, including international.

Pay range for this opportunity is $50,250.00 - $70,350.00. This position is eligible for [BONUS PARTICIPATION] OR a [INSERT COMMISSION RATE RANGE, IF APPLICABLE] commission.

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.

Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-Time Employees are also eligible for short-term disability. Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid Holidays. Part-time employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid Holidays based on their standard hourly work week. Full-Time employees are eligible for four weeks of paid parental leave. Part-time employees also receive paid parental leave, pro-rated based on their standard hourly work week.

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.