Senior Quality Assurance and Regulatory Affairs, Risk Manager

Job Description:

  • Support development and continuous improvement of the Quality Management System in accordance with FDA QMSR / 21 CFR Part 820 and ISO 13485
  • Support design controls and maintain DHF and technical documentation, including requirements, specifications, V&V evidence, risk documentation, traceability, labeling inputs, and release evidence
  • Participate in design reviews and assess product and software changes for quality and regulatory impact
  • Support global regulatory submissions and post-market regulatory activities
  • Contribute to CAPA, PMS, validation, supplier control, audit readiness, document control, and change control activities
  • Serve as Risk Manager for assigned medical device software products
  • Establish and maintain Risk Management Plans and Risk Management Files according to ISO 14971:2019
  • Facilitate hazard identification, risk analysis, risk evaluation, risk controls, verification of risk control effectiveness, and residual risk evaluation
  • Integrate risk management with the software lifecycle, cybersecurity, usability engineering, CAPA, complaints, PMS, and design changes
  • Identify opportunities to use AI and automation to improve regulatory and quality workflows
  • Ensure AI-assisted workflows have appropriate verification, quality controls, and human oversight

Requirements:

  • 5+ years of relevant experience in medical device Quality Assurance, Regulatory Affairs, risk management, medical device software, or a closely related regulated field
  • Strong knowledge of FDA requirements, FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304
  • Experience with SaMD or software-containing medical devices, design controls, DHF/technical documentation, V&V, traceability, CAPA, PMS, audits, and/or regulatory submissions
  • Practical experience with medical-device risk management, including risk analysis, risk controls, verification evidence, and Risk Management Reports
  • Strong analytical, documentation, and technical-writing skills
  • Professional fluency in written and spoken English
  • Ability to work independently and effectively with global cross-functional teams
  • Comfort applying AI, automation, data analytics, or digital tools in regulated environments
  • Bachelor's or master's degree in biomedical engineering, software engineering, computer science, health technology, life sciences, quality engineering, regulatory affairs, or a related technical/scientific discipline; equivalent relevant professional experience may also be considered
  • Training or demonstrated expertise in ISO 14971 risk management is strongly preferred
  • Additional experience or education in AI, automation, data science, or digital quality systems is an advantage

Benefits:

  • Eligibility for a 5% annual bonus
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • Disability insurance
  • Tax-saving spending accounts
  • 401(k) plan with employer match
  • Tuition reimbursement
  • Paid company holidays
  • Paid personal time off
  • Paid sick time
  • Flexible paid time off policy for salaried employees
  • Comprehensive benefits package for employees working at least 30 hours per week
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