Hybrid Principal Regulatory Affairs Specialist

Posted last week

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About the role

  • Develop and execute the regulatory strategy for new product development, design changes, and field safety corrections
  • Author 510K submissions, pre-sub documents, EUMDR tech files, and contribute to international regulatory submissions
  • Participate in strategic product development, design solutions from concept phase to product delivery phase
  • Provide regulatory guidance throughout design and development
  • Act as a Regulatory Subject Matter Expert (SME) and manage special projects across product lines
  • Monitor global regulatory landscapes and guide cross-functional teams on regulation changes
  • Communicate new changes and facilitate interpretation to ensure compliance
  • Support product defect assessments, health hazard evaluations, corrections and removals as a regulatory SME
  • Review labeling, marketing materials, and claims substantiation evidence

Requirements

  • Minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments
  • Proven expertise in Software as a Medical Device (SaMD), IEC 82304 (safety) and IEC 81001-5-1/ISO 27001 (Information Security)
  • Experience authoring multiple 510Ks, EUMDR tech files, and Pre-Sub notifications submitted to the FDA
  • Familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards and regulations
  • Knowledge and understanding of the software development lifecycle (SDLC)
  • Minimum of a Bachelor's Degree (Required)
  • RAPS certification - preferred
  • Proven ability to build strong relationships with internal and external stakeholders

Benefits

  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement

Job title

Principal Regulatory Affairs Specialist

Job type

Experience level

Lead

Salary

$114,750 - $183,600 per year

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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