About the Role
Our client is seeking an experienced Quality & Regulatory Affairs Manager to lead the establishment of the Quality Management System and oversee regulatory strategy and execution for the endoscopic platform. This role will be responsible for implementing and maintaining an ISO 13485:2016-compliant Quality Management System, as well as leading preparation for FDA 510(k) submission and certification through the Medical Device Single Audit Program (MDSAP). The successful candidate will report directly to the CEO and work closely with engineering, external vendors, and regulatory advisors to ensure compliance and timely achievement of key regulatory milestones.
Responsibilities
* Establish, implement, and maintain the company's ISO 13485:2016 Quality Management System (QMS)
* Lead the company's pathway to ISO 13485 certification via MDSAP, including audit readiness and certification activities
* Develop and manage quality system documentation, including SOPs, work instructions, and records
* Ensure compliance with design controls, risk management, and document control processes
* Oversee preparation and submission of FDA 510(k) documentation in collaboration with internal and external stakeholders
* Act as the primary point of contact with regulatory bodies, notified bodies, and external regulatory consultants
* Support supplier qualification, monitoring, and quality agreements with external vendors
* Drive internal audit programs, CAPA processes, and continuous improvement initiatives
* Provide regulatory guidance across product development to ensure alignment with applicable standards and requirements
Qualifications
* Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline
* 5+ years of experience in Quality and Regulatory Affairs within the medical device industry
* Strong understanding of medical device regulations, standards, and quality system requirements
* Demonstrated experience implementing and maintaining ISO 13485:2016 QMS
* Direct experience preparing or supporting FDA 510(k) submissions
* Experience with MDSAP audits and certification processes
* Experience working with external consultants, notified bodies, and regulatory agencies
* Familiarity with ISO 14971 risk management processes
* Working knowledge of additional regulatory frameworks (e.g., EU MDR, TGA)
If you are interested in this position please apply or email bwalsh@i-pharmconsulting.com
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