Overview
The RA/QA Manager will oversee regulatory affairs and quality assurance activities in the U.S., ensuring compliance with applicable regulations, guidance, and standards. This role combines leadership in inspection readiness, quality system management, regulatory support for projects, and cross-functional collaboration to foster a strong culture of quality and compliance across the organization.
Responsibilities
* Act as U.S. Agent and manage all U.S.-based regulatory affairs, including approval of marketing materials, regulatory input on projects, and engagement with FDA, consultants, and key stakeholders.
* Provide regulatory advice, maintain accurate documentation, and ensure compliance with applicable regulations, standards, and internal procedures.
* Lead and manage quality assurance activities, including NCR management, complaint handling, distribution quality, supplier and internal audits, and document control.
* Oversee software regulatory assessments and validation in collaboration with global teams.
* Train U.S. staff on quality management systems (QMS) and applicable regulations.
* Participate as part of the U.S. management team, guiding strategy and ensuring regulatory compliance.
* Support purchasing and ordering activities within established budgets and procedures.
* Ensure compliance with quality system policies, regulations, and continuous improvement initiatives.
Qualifications
* Bachelor’s degree in a related field.
* Proven sales success in medical devices; orthopedics/orthobiologics experience preferred.
* Strong knowledge of QSR, ISO 13485, MDSAP; FDA 510(k) submission experience required.
* Background in Quality Assurance and Regulatory Affairs at a commercial site.
* Skilled in labeling/marketing approvals and cross-functional compliance (customer service, logistics, suppliers, marketing).
* Demonstrated ability to improve QMS processes, update SOPs, and drive proactive compliance.
Note: This job description is not exhaustive and may be condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job, and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as negotiated to meet the organization's ongoing needs.
Legacy MedSearch has been consecutively featured on Forbes' list of Best Recruiting Firms in America for 6 years running (2019–2024).
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