Job Type:

Long-Term Consulting Role / Potential for a Full-Time Position • Consulting payment to be determined; full-time position salary posted above•

Role Description:

We are seeking a Regulatory Affairs & Quality Assurance consultant to lead the company's Quality Management System (QMS) update efforts, with an immediate focus on QMSR transition activities and broader QMS improvements. This individual will provide strategic leadership to the Quality and Regulatory team, drive compliance initiatives, and help build scalable processes that support future growth. The role offers the opportunity to transition into a permanent position for the right candidate as the organization continues to expand.

Key Responsibilities:

Lead the company's QMSR transition, including gap assessments, remediation planning, implementation, and effectiveness verification. Drive Quality Management System (QMS) updates and improvements to strengthen compliance, scalability, and operational efficiency. Assess existing quality and regulatory processes and implement enhancements aligned with

QMSR, ISO

13485, and industry best practices. Provide leadership, mentorship, and strategic guidance to the Quality and Regulatory team while building sustainable processes and capabilities. Support audit and inspection readiness activities, including internal audits, management reviews, compliance metrics, and remediation efforts. Collaborate with Engineering, Clinical, and Operations teams to ensure quality and regulatory requirements are effectively integrated into business and product development processes.

Skills & Qualifications:

5+ years of experience in Regulatory Affairs and Quality for U.S. Class II or Class III medical devices, preferably within digital health or health technology environments. Bachelor's degree in disciplines related to life sciences and engineering required; advanced degree preferred. Demonstrated leadership experience in Regulatory Affairs and/or Quality within medical device or digital health environments, including oversight of U.S. Class II products. Deep understanding of

ISO 13485, ISO 14971, IEC 62304, IEC

62366, and the evolving QMSR regulatory framework. Ability to independently drive regulatory and quality initiatives in a fast-paced, scaling organization. Experience supporting software-driven or integrated hardware/software medical technologies (SaMD strongly preferred). Strong technical writing capabilities with the ability to translate complex regulatory requirements into clear, actionable documentation.

Pay:

$160,000.00 - $180,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

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