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Director Quality Assurance Regulatory Affairs

Director Quality Assurance Regulatory Affairs

BioTalentCarlsbad, CA, US
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Director of Quality & Regulatory Affairs – Medical Devices

  • ?? Location : North San Diego | ?? Full-time | ?? Medical Device Industry

We are seeking a Director of Quality & Regulatory Affairs to provide strategic leadership and oversight of compliance, regulatory, and quality activities for our breakthrough medical technologies. This is a high-impact role responsible for ensuring patient safety, regulatory success, and operational excellence as we bring innovative devices to market.

Compliance & Risk Management

  • Act as Management Representative of the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA Quality System Regulation (QSR) , and global standards for sterile implantable and electronic devices.
  • Lead Risk Management activities per ISO 14971 , guiding the Risk Management Team in assessing product changes and monitoring design / development activities for compliance with design controls.
  • Manage internal audits , post-market surveillance, regulatory notifications, and customer communications related to complaints and investigations.

    • Regulatory Affairs

  • Define regulatory pathways for new products and product changes (e.g., Letter to File, 510(k) submissions).
  • Coordinate with regulatory consulting partners to prepare and execute 510(k) submissions for Class II devices
  • Maintain oversight of labeling, documentation, and regulatory assessments throughout the product lifecycle.

    • Design Verification & Validation (V&V)

  • Review design documentation & support development of V&V protocols to confirm conformance to specifications, standards, and process controls using statistically valid methods.
  • Oversee data collection and reporting for V&V results, software validation, hardware testing, and performance testing protocols.

    • Quality Assurance & Operations

  • Oversee management of Nonconforming Materials (NCMR) , Corrective and Preventive Actions (CAPA), and supplier qualification metrics.
  • Guide creation and implementation of inspection and test methods , improving manufacturing quality, product assembly, and inspection integrity.
  • Contribute to building and maintaining the Design History File (DHF) and Device Master Record (DMR)
  • Lead document control and change order management across the organization.

    • Qualifications

  • Bachelor's degree in engineering, life sciences, or related field (advanced degree preferred).
  • 10+ years in the medical device industry , with at least 5 years in a leadership role.
  • Deep knowledge of FDA / QSR, ISO 13485, ISO 14971 and related international standards.
  • Experience leading 510(k) preparation and submissions for Class II devices.
  • Technical proficiency in MS Office, Matlab, PLM systems (Agile) , and application of statistical techniques.
  • Strong interpersonal, leadership, and communication skills to influence across departments and drive compliance.
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