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OPEN POSITION

Research Scientist, Quality and Compliance

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Job Description

Harbor Labs is currently seeking candidates for the Research Scientist, Quality and Compliance position. This position works under under the Director of Regulatory Science to contribute both independently and in collaboration with senior staff to support Harbor Labs’ clients in meeting medical device regulatory and quality system requirements. The Research Scientist will perform technical reviews of client documentation, identify gaps and inefficiencies, and propose improvements that enhance compliance and product readiness. This role also supports internal process development and aligns closely with Harbor Labs’ cybersecurity and engineering teams to ensure that product development practices meet both regulatory expectations and industry best practices.

This position calls for a detail-oriented, highly analytical professional with strong working knowledge of medical device regulations, quality system standards, and the intersection of compliance, cybersecurity, and product engineering.

Typical Activities Include:

  • Reviewing client documentation for gaps and inconsistencies against FDA and ISO standards
  • Working with technical teams to remediate deficiencies and ensure design compliance
  • Developing and optimizing quality system processes for electromechanical and SaMD products
  • Training and coaching clients and peers on applicable quality and regulatory requirements
  • Supporting regulatory strategy and documentation for FDA 510(k), PMA, and pre-submission filings
  • Collaborating with client leadership and engineering teams to align design processes with regulatory expectations
  • Preparing responses and supplemental materials to regulatory agency inquiries
  • Monitoring and interpreting regulatory updates to ensure continued client compliance

Education:

Preferred education level: B.S. in Engineering, Life Sciences, Quality Assurance, or related field

Required Qualifications:

  • 3+ years of experience in regulatory affairs and/or quality assurance for medical devices
  • Demonstrated knowledge and application of U.S. FDA regulations (21 CFR 820) and international standards including ISO 13485, ISO 14971, IEC 62304, and EU MDR
  • Strong technical writing and documentation skills across diverse audiences
  • Experience communicating regulatory and quality concepts to both technical and non-technical stakeholders

Preferred Additional Qualifications:

  • Experience supporting both electromechanical devices and Software as a Medical Device (SaMD) products
  • Regulatory Affairs Certification (RAC) or CQE/CQM certification
  • Familiarity with direct interactions with the FDA or other regulatory bodies through audits or submissions

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Qualified candidates who may only meet a subset of these qualifications are nonetheless encouraged to submit their resumes for consideration.

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