Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager

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Topcon Healthcare is looking for an experienced Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager to support our medical device software and digital health products.

This is a unique dual role combining approximately 50% QARA and 50% product risk management. You will work closely with global Product, Engineering, Clinical, Cybersecurity, Usability, and QARA teams to ensure our products meet applicable quality, regulatory, and safety requirements throughout their lifecycle.

A key part of the role is helping us modernize QARA. You will identify opportunities to use AI and automation to improve regulatory and quality workflows while ensuring appropriate controls, verification, and human oversight.

This position is based in the United States, Eastern Time Zone, enabling close collaboration with our international teams.

What You’ll Do

Quality & Regulatory Affairs

• Support the development and continuous improvement of our Quality Management System in accordance with applicable requirements, including 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.

Product Risk Management

• Serve as Risk Manager for assigned medical device software products.
• Establish and maintain Risk Management Plans and Risk Management Files in accordance with 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, including IEC 62304, cybersecurity, usability engineering, CAPA, complaints, PMS, and design changes.

AI & QARA Automation

You will help us evolve from predominantly manual regulatory processes toward more structured and automated approaches. Examples include:

• automated DHF and technical-documentation completeness checks;
• requirements, risk, and evidence traceability;
• detection of missing or inconsistent regulatory evidence;
• CAPA and PMS data analysis;
• Audit evidence preparation;

You will ensure that AI-assisted workflows have appropriate verification, quality controls, and human oversight, particularly where safety or regulatory judgments are involved.

What You Bring

• 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 medical device regulations and standards, particularly 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.

AI & Digital Mindset

We are particularly interested in candidates who are comfortable applying AI, automation, data analytics, or digital tools in regulated environments.

You should be curious about how AI can improve QARA processes and risk management, and understand where expert human judgment and oversight remain essential.

Education

• 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 demonstr ated 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.

Base Pay

Expected Base Pay Range: $100,000 to $120,000 Annualized

The base pay range included is a projected hiring range for a position, level and potential work location(s) listed. Topcon provides the compensation range that it in good faith believes it might pay and/or offer for this position. This compensation range is based on a full-time schedule.

Bonus eligible

In addition to base pay, compensation for this position includes eligibility for a 5% annual bonus.

Benefits*

Topcon offers a comprehensive benefit package for this position including medical, dental, vision, life insurance, disability insurance, tax saving spending accounts a 401(k) plan with employer match, tuition reimbursement in addition to other perks and benefits. We also offer time off for our employees to recharge. Our employees are eligible for paid company holidays, paid personal time off, and paid sick time that meets or exceeds state/local requirements.

Topcon reserves the right to ultimately pay more or less than the posted range and offer additional benefits and other compensation; individual candidate compensation may be determined based on individual skills, experience, training, certifications, education, final work location and other factors not related to an applicant’s sex or other status protected by local, state, or federal law. Changes in the position level, location or other factors associated with the role may change the final determined compensation. The recruiter can provide additional information during the hiring process.

• Topcon time off policies can vary between roles which are exempt or non-exempt. For hourly (“non-exempt”) employees, we offer personal paid time off which accrues in accordance with local standards. For salaried (“exempt”) employees, we offer a flexible paid time off policy giving you flexibility to take time when needed, while supporting business needs. All paid time off policies are in accordance with or exceeding local law. Employees working at least 30 hours per week are eligible for our Health and Welfare benefit package.

EEO Statement

We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.