Aircraft Regulatory Specialist
2 months ago
Quality Assurance and Regulatory Affairs Lead
Reed Engineering has partnered with an industry leading Biotech at the forefront of diabetes research. My client has an immediate requirement for someone to lead the quality and regulatory projects and functions. You will maintain and improve robust quality management systems and ensure adherence to regulatory requirements throughout the development lifecycle of our medical device products. There is a specific need for the candidate to have experience within software development standards, in particular IEC 62304, IEC 62366 and with SaMDs.
Key Responsibilities
- Quality Management System: Implement, maintain, and improve a comprehensive QMS in accordance with relevant quality standards.
- Regulatory Compliance: Stay updated on global regulatory requirements.
- Quality Assurance: Oversee quality assurance processes, including design controls, risk management, verification and validation activities.
- Audits and Inspections: Coordinate and manage internal audits, lead external audits and regulatory inspections, and drive continuous improvement initiatives.
Qualifications and Experience
- Bachelor's degree or higher in a relevant scientific discipline.
- Minimum of 5 years of experience in quality assurance and regulatory affairs roles within the medical device industry.
- Strong understanding of risk management principles, design controls, verification and validation processes, post-market surveillance, and vigilance requirements for medical devices.
- Proven experience in preparing and submitting regulatory filings, managing regulatory interactions, and facilitating successful product approvals.
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