Hybrid Quality and Regulatory Affairs Specialist

Posted 4 days ago

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About the role

  • Supports quality operations & documentation control ensuring alignment with company procedures and global regulatory requirements
  • Maintains controlled documents and records throughout their lifecycle
  • Contributes to the development and revision of controlled documents, quality records, and design documentation in collaboration with cross-functional teams
  • Executes and supports QMS processes including non-conformance, CAPA, change control, and complaint handling activities
  • Assists with investigation documentation, tracking, trending, and closure to support continuous improvement and regulatory compliance
  • Assists in maintaining vendor qualifications and supplier agreements
  • Provides regulatory support in the preparation, review and maintenance of regulatory submissions, dossiers, and technical files for global filings
  • Assists with audit preparations and inspection readiness activities and serves as support during external audits
  • Works closely with Product Development, Engineering, and Operations teams to support compliance and quality objectives
  • Supports project timelines for quality and regulatory deliverables
  • Assists in developing product documentation and participates in verification that products consistently meet specification, safety, identity, and performance requirements

Requirements

  • Bachelor’s Degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or related discipline
  • Two (2) years of related experience in Quality Assurance or Regulatory Affairs in a medical device or IVD environment
  • Working knowledge of related industry regulations and standards
  • Experience with quality management systems and document control processes.
  • Authorization to work in the United States, or appropriate authorization to work in the applicant’s current home country (Indica Labs does not sponsor work visas)

Benefits

  • Health insurance
  • 401(k) matching
  • Paid time off
  • Professional development opportunities

Job title

Quality and Regulatory Affairs Specialist

Job type

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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