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

Topcon Healthcare Inc.; New Jersey; Hybride; USD 100 000 - 120 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with employer match

Tuition reimbursement

Paid holidays

Résumé du poste

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

The role is a dual responsibility—approximately 50% QARA and 50% product risk management—working with global teams to ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, and IEC 62304. Flexible AI-enabled workflows are emphasized.

Qualifications

• 5+ years of relevant experience in medical device QA, regulatory affairs, risk management, or related field.
• Strong knowledge of medical device regulations and standards, especially FDA requirements, QMSR / 21 CFR 820, ISO 13485, ISO 14971, IEC 62304.
• Experience with SaMD or software-containing medical devices, design controls, DHF/technical documentation, V&V, traceability, CAPA, PMS, audits, and regulatory submissions.
• Practical experience with medical-device risk management, including risk analysis, controls, verification evidence, and risk reports.
• Strong analytical, documentation, and technical-writing skills; fluent English; ability to work with global teams.
• Able to apply AI/automation concepts within regulated environments with appropriate oversight.

Responsabilités

• Support development and improvement of the Quality Management System per FDA QMSR 21 CFR 820 and ISO 13485.
• Maintain design controls, DHF, and technical documentation including requirements, specs, V&V, risk docs, traceability, labeling, and release evidence.
• Participate in design reviews and assess quality and regulatory impact of changes.
• Support global regulatory submissions and post-market activities.
• Contribute to CAPA, PMS, audits, document control, and change control; integrate risk management with software lifecycle.
• Act as Risk Manager for assigned medical device software products; develop Risk Management Plans per ISO 14971.

Connaissances

QARA regulatory knowledge

Quality Assurance

Risk management

FDA QMSR / 21 CFR Part 820

ISO 13485

IEC 62304

SaMD experience

Regulatory submissions

Regulatory documentation

English proficiency

Formation

Bachelor's or Master's in biomedical engineering / regulatory affairs / related field

Outils

ISO 14971 risk management

Description du poste

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.

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

• 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 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.

Topcon Healthcare sees eye health differently. Our vision is to empower providers with smart and efficient technologies for enhanced patient care. Keeping pace with the ever-changing landscape of the healthcare industry, we offer the latest integrated solutions including advanced multimodal imaging, vendor-neutral data management and groundbreaking remote diagnostic technology. A globally-oriented business, Topcon is focused on developing solutions towards solving societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, access to healthcare and physician shortages. By investing in value-driven innovations, Topcon works to enable people to enjoy good health and a high quality of life.