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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