The Sr. Regulatory Affairs & Quality Assurance Associate position is located in Tosoh Bioscience, Inc.'s Grove City, OH offices. Tosoh Bioscience, Inc. is part of the Japanese global organization by the same name. This division of Tosoh Bioscience, Inc. is the medical diagnostic equipment division, supporting sales groups in both North, Middle and South America. This position is under the direction of the Director and Manager of Quality Assurance & Regulatory Affairs and performs critical functions. in support of Tosoh Bioscience Inc.'s Quality System in compliance with FDA Code of Federal Regulations (21 CFR 820), ISO 13485, ISO 14971, and Tosoh Bioscience Quality Policies and Procedures. In addition, this position provides supervisory support of Tosoh Bioscience, Inc. Quality Assurance and Quality Control laboratory and personnel.
ISO Certification and FDA GMP Responsibilities:
- Manage ISO Certification requirements and ensure compliance with ISO and FDA regulations.
- Maintain Quality System Manual & Quality Policy.
- Conduct training on quality and regulatory policies and procedures.
- Manage all internal and external audits; Report all non-conformities to QA & RA Management.
- Monitor, implement, and improve critical quality elements, such as document/design control, risk management, supplier qualification, materials management, QC testing and acceptance criteria review, deviations/rework, customer-related processes, internal audits, and regulatory affairs filings;
- Design Control and Process Validation protocol review supporting Design Transfer, Verification (Pre-Clinical), Validation (Clinical Validation), Product Launch, and Post-Market Surveillance;
- Review, management, and closure of SCAPA, CAPA, and NCR;
- Review and maintain Change Orders and ensure approvals have been obtained within timeframes outlined
- Initiate, review, manage and update Work Instructions
- Manage and review Label and Labeling approvals in collaboration with Regulatory Affairs Specialists;
- Improve, Implement, and Manage Quality System Document Control
- Manage and coordinate Complaints and Technical Support, Recalls, and Material Review Dispositions in collaboration with the Technical Services Manager & QA Complaints and Compliance Reporting Specialist;
- Support the Quality System Management Representative
- Scribe and post meeting minutes
- Report on audit findings, CAPA, SCAPA, NCR, Supplier Status, and Recalls/Vigilance Reporting.
- Submit MDRs and Recall advisories according to FDA requirements and ensure that all follow-up activities are completed and are communicated to manufacturer as required
- Complete required registration and reports as required by Federal Regulations
- Participate in FDA Inspections as required
- QA Laboratory Management
- Manage laboratory personnel in accordance with Tosoh policies. This includes but is not limited to:
- Recruitment/staffing plans
- Skills assessment
- Conduct performance reviews and discussions
- Performance development
- Project assignments
- Interpret and enforce Company Policies and Practices
- Monitor QA retain to guarantee that each new lot number has the appropriate quantities sequestered for potential troubleshooting
- Manage manufacturing QA data trending
- Manage the processes for data reduction / submission of all QA lab projects including R & D requested assistance, proficiency surveys, control material value assignments, in-house product related studies, lot-to-lot comparison studies, complaint investigations.
Supervisory Responsibilities Include: