What are the responsibilities and job description for the Senior Regulatory Specialist position at Disability Solutions?
Responsibilities
The Senior Manager, GxP Quality Systems, is responsible for:
- Developing and implementing the Quality Management System (QMS) to ensure compliance with Good Practice (GxP) regulations.
- Leading quality assurance operations, including internal and external audits.
- Collaborating with cross-functional teams to maintain the highest quality standards.
- Staying up-to-date with current and emerging regulations impacting medical devices and combination products.
- Ensuring organizational adherence to relevant regulations.
- Investigating product and service quality issues, deviations, and non-conformances.
- Implementing effective corrective and preventive actions (CAPAs).
