Senior Quality Assurance and Regulatory Affairs, Risk Manager

This is a fully remote position, open to applicants in Florida, +3 more states.

📋 Description

• Assist in the development and ongoing enhancement of the Quality Management System following FDA QMSR / 21 CFR Part 820 and ISO 13485 standards.

• Aid in design controls and maintain Design History Files (DHF) and technical documentation, which includes requirements, specifications, verification and validation (V&V) evidence, risk documentation, traceability, labeling inputs, and release evidence.

• Engage in design reviews and evaluate product and software modifications for their quality and regulatory implications.

• Support global regulatory submissions and activities related to post-market regulation.

• Contribute to Corrective and Preventive Actions (CAPA), Post-Market Surveillance (PMS), validation, supplier management, audit preparedness, document control, and change control processes.

• Act as Risk Manager for designated medical device software products.

• Develop and maintain Risk Management Plans and Risk Management Files in compliance with ISO 14971:2019.

• Facilitate the processes of hazard identification, risk analysis, risk evaluation, risk control, verification of risk control effectiveness, and assessment of residual risk.

• Incorporate risk management into the software lifecycle, including aspects of cybersecurity, usability engineering, CAPA, complaints management, PMS, and design modifications.

• Identify potential to leverage AI and automation to enhance regulatory and quality workflows.

• Ensure that AI-assisted workflows include suitable verification, quality controls, and necessary human oversight.

⛳️ Requirements

• A minimum of 5 years of relevant experience in medical device Quality Assurance, Regulatory Affairs, risk management, medical device software, or a closely related regulated sector.

• In-depth knowledge of FDA regulations, FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.

• Familiarity with Software as a Medical Device (SaMD) or software-containing medical devices, design controls, DHF/technical documentation, V&V, traceability, CAPA, PMS, audits, and/or regulatory submissions.

• Hands-on experience with medical device risk management, covering risk analysis, risk controls, verification evidence, and Risk Management Reports.

• Strong analytical abilities, documentation skills, and proficiency in technical writing.

• Professional proficiency in both written and spoken English.

• Capability to work autonomously and collaboratively with global cross-functional teams.

• Comfort with the application of AI, automation, data analytics, or digital tools within regulated settings.

• 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 field; equivalent relevant professional experience may also be taken into account.

• Training or proven expertise in ISO 14971 risk management is strongly preferred.

• Additional qualifications or experience in AI, automation, data science, or digital quality systems is considered a plus.

🏝️ Benefits

• Eligibility for a 5% annual bonus.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance options.

• Life insurance provision.

• Disability insurance benefits.

• Tax-saving spending accounts.

• 401(k) plan with employer matching contributions.

• Tuition reimbursement assistance.

• Paid company holidays.

• Paid personal time off.

• Paid sick leave.

• Flexible paid time off policy for salaried staff.

• Robust benefits package for employees working a minimum of 30 hours per week.