Site Compliance Manager

Role Summary

Site Compliance Manager responsible for managing Quality Engineers and Quality Trainer activities supporting Product Surveillance for Medical Devices and Combination products. Oversees adherence to FDA regulations and other applicable regulatory requirements, maintains quality system documentation, and coordinates internal, supplier, and regulatory audits. Leads the Global Product Surveillance CAPA program and supports quality management reviews.

Responsibilities

• Responsible for Quality System and Compliance investigations and support for processing of complaint/adverse event files following global complaint handling regulations, device tracking, clinical protocol data intake and internal procedures. Analyze processes and information to determine reportability under applicable regulations.
• Conduct, review and approve CAPA and Non-Conformance investigations. Monitor and support Quality Engineers approving investigations. Lead the CAPA and Non-Conformance program for Global Product Surveillance.
• Develop departmental metrics for local and segment management reviews and ad hoc requests.
• Oversee supplier quality compliance to support complaint handling in accordance with company policies.
• Assess opportunities for interdepartmental and site harmonization of practices and quality system requirements.
• Review and approve documents pertaining to department Quality Systems (SOPs, DOPs, forms, etc.).
• Provide generalized Quality System, company, departmental and product knowledge as required.
• Collect data and analyze as required to support inquiries from Regulatory bodies, internal and external customers.
• Monitor department processes and workflow compliance to regulatory and department procedures and policies and identify opportunities for improvement.
• Responsible for Regulatory audit preparation and execution. Host audits on site and travel to other sites to support audits and inspections as needed. Maintain internal audits schedule and organize audits to self-identify compliance non-conformities. Provide leadership and design for back room audit support activities and document reviews.

Qualifications

• Bachelor’s degree (scientific degree preferred) and seven to eight years related experience in a regulated industry or medical environment. Supervisory experience preferred but not required.
• Knowledge of applicable regulations including 21 CFR 803, 21 CFR 820, 21 CFR 821, 21 CFR 4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016, and other international complaint handling and vigilance regulations.
• Experience in TrackWise and eLMS preferred.
• Ability to communicate and collaborate with multiple departments to ensure goals and strategies are met.
• Ability to initiate or suggest plans to motivate workers to achieve work goals.
• Ability to provide accurate and complete information in a prompt manner.
• Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities.
• Ability to work with mathematical concepts such as probability and statistical inference and apply fractions, percentages, ratios, and proportions to practical situations.

Education

• Bachelor’s degree (scientific degree preferred) with seven to eight years of relevant experience in a regulated industry or medical environment.

Skills

• Regulatory compliance and quality systems management
• CAPA and Non-Conformance investigations
• Internal, supplier, and regulatory audits
• Data analysis and metrics development
• Cross-functional collaboration and communication
• Knowledge of FDA regulations (21 CFR), EU MDR, ISO 13485:2016
• GMP/cGMP environments