Quality & Regulatory Compliance Specialist

at  Steris

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.

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.

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 200

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