For over 90 years, Topcon’s vision has been to solve societal challenges around the globe. In healthcare, we are developing innovations that improve patients’ health and quality of life.
We empower eye care providers with advanced imaging, diagnostic solutions, and intelligent data technology. Our robotic devices deliver simplicity without compromise, by capturing clear images with the push of a button.
By joining Topcon Healthcare, you become part of a growing, diverse, global team. With office locations throughout North America, whether you are on-site, remote, or hybrid, our culture empowers you to contribute to company and personal success each day. At Topcon Healthcare, you can grow your career, gain new perspectives, and help address society’s most pressing challenges. If you have drive, passion, and a desire to be part of a collaborative team, we want to hear from you.
At Topcon Healthcare, we don’t wait for the future. We invent it. Join us.
Learn more about working with us at topconcareers.com
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…