Regulatory Compliance Expert
5 days ago
Job Summary
Ignite Human Capital is seeking a Regulatory Compliance Expert to join our quality assurance team. This role will focus on ensuring that our products meet regulatory requirements and comply with industry standards.
Duties and Responsibilities
- Develop, review, and validate standard operating procedures (SOPs), testing protocols, and compliance documentation to ensure adherence to regulatory requirements and internal guidelines.
- Manage quality-related activities, including addressing deviations, non-conformities, and customer feedback.
- Lead investigations for corrective and preventive actions (CAPAs).
- Assess and document the impact of deviations and customer complaints on product quality.
- Review and approve risk analyses related to engineering changes and recalls.
- Oversee engineering change orders and maintain accurate documentation; collaborate with various teams to resolve quality-related issues.
- Collaborate with manufacturing teams to integrate risk management practices and ensure compliance throughout the product development lifecycle.
- Engage in both internal and external compliance audits.
- Provide ongoing support and training to quality assurance team members.
- Contribute to the development of training initiatives aimed at enhancing product quality.
- Analyze quality metrics and trends for continuous improvement.
Requirements
- Bachelor's degree in a relevant scientific field or equivalent experience; an engineering degree is preferred.
- Minimum of 5 years in quality assurance, preferably within the biotech or medical device sectors, with experience in a regulated environment.
Salary Range: $90,000 - $120,000 per year, depending on experience.
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