Regulatory Affairs Specialist
1 week ago
Reed Scientific is seeking a highly experienced Quality Assurance and Regulatory Affairs Lead to join our team. As a key member of our organization, you will be responsible for maintaining and improving our robust quality management systems and ensuring adherence to regulatory requirements throughout the development lifecycle of our medical device products.
Key Responsibilities- Quality Management System: Implement, maintain, and improve a comprehensive QMS in accordance with relevant quality standards (e.g., ISO 13485, MDSAP).
- Regulatory Compliance: Stay updated on global regulatory requirements (e.g., FDA, EU MDR, UK MDR) and ensure timely and compliant submissions for product approvals, licence renewals etc.
- 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.
- 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.
- In-depth knowledge of QMS standards (e.g., ISO 13485, MDSAP), medical device regulations (e.g., FDA, EU MDR, UK MDR, Health Canada), and software development lifecycle methodologies.
- 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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