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Regulatory Affairs Specialist
1 month ago
Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to lead our quality and regulatory projects and functions.
Key Responsibilities:
* Implement, maintain, and improve a comprehensive Quality Management System in accordance with relevant quality standards
* Stay updated on global regulatory requirements and ensure adherence to regulatory requirements throughout the development lifecycle of our medical device products
* Oversee quality assurance processes, including design controls, risk management, verification and validation activities
* Coordinate and manage internal audits, lead external audits and regulatory inspections, and drive continuous improvement
Requirements:
* 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
About Us:
We are a leading Biotech company at the forefront of diabetes research. We are committed to delivering innovative medical devices that meet the highest standards of quality and regulatory compliance.
What We Offer:
* Competitive salary and benefits package
* Opportunity to work with a talented team of professionals
* Collaborative and dynamic work environment
If you are a dedicated and experienced QA/RA professional with a passion for ensuring the quality and regulatory compliance of innovative medical devices, we encourage you to apply for this exciting opportunity.
