This is a remote position. Work Schedule: 8 AM till 12 PM Pacific
We are seeking a knowledgeable and detail-oriented Regulatory Affairs & Quality Specialist to manage the regulatory lifecycle of Class IIa medical devices. These software-based or integrated systems interface with imaging modalities such as CT, MRI, and Ultrasound, ensuring the appropriate storage, routing, and access of diagnostic medical images. This role ensures compliance across product development, registration, and post-market phases under EU MDR, FDA, and ISO 13485 frameworks.
Prepare and maintain regulatory submissions including EU MDR Technical Files and FDA 510(k) applications.
Ensure compliance with regulatory standards: EU MDR (2017/745), 21 CFR 820, 21 CFR Part 11, ISO 13485, IEC 62304 (software lifecycle), and ISO 14971 (risk management).
Collaborate with product, engineering, and clinical teams to define and document intended use, clinical benefits, and performance claims.
Evaluate and document software changes using MDCG guidelines for significant change assessment.
Monitor evolving regulations including AI/ML in medical software, DICOM interoperability, and cybersecurity.
Interface with Notified Bodies and Competent Authorities during audits and regulatory reviews.
Support post-market surveillance activities including vigilance reporting and periodic safety updates.
Maintain documentation and control of all regulatory files within the QMS.
Support and maintain ISO 13485-compliant Quality Management Systems.
Manage documentation, CAPAs, internal audits, and audit readiness.
Use electronic QMS tools (e.g., ComplianceQuest) to track nonconformance, training, and document control.
Collaborate cross-functionally to ensure effective quality processes.
Support external audits (Notified Bodies, FDA) and drive continuous improvement initiatives.
Bachelor’s degree in Engineering, Life Sciences, or Regulatory Affairs.
3+ years of experience in regulatory affairs within the medical device industry (ideally involving imaging systems, PACS, or diagnostic software).
Strong knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304.
Proven experience with Technical File development and regulatory body communication.
Excellent written and verbal communication skills.
Experience with PACS, RIS, or vendor-neutral archives.
Familiarity with DICOM, HL7, cybersecurity in medical software.
Knowledge of FDA requirements for software-based medical devices.
RAC certification (EU or U.S.).
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