Senior Quality & Regulatory Manager

Insight Global; Beachwood (OH); Presencial; USD 120 000 - 170 000; Tempo integral

Resumo da oferta

Insight Global is seeking an experienced Quality Systems and Regulatory Affairs professional to maintain and improve QMS for SaMD and cloud-based products. You will lead regulatory submissions (FDA 510(k), EU MDR) and ensure ongoing compliance with FDA, ISO, and IEC standards across the product lifecycle.

The role emphasizes risk management, software lifecycle practices, cybersecurity documentation, and cross-functional collaboration with Engineering, Product, and Operations.

Qualificações

• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related technical field.
• 5–8 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Experience with software as a medical device (SaMD), medical device software, and cloud deployment, strongly preferred.
• Demonstrated experience managing a QMS, supporting audits and regulatory inspections, and maintaining quality and regulatory documentation.
• Experience supporting or leading regulatory submissions, ideally including FDA 510(k) submissions, EU MDR documentation, and international registrations.
• Working knowledge of FDA 21 CFR Part 820 / FDA QMSR, ISO 13485, ISO 14971, CAPA, design controls, and software lifecycle practices such as IEC 62304.

Responsabilidades

• Maintain, and continuously improve the Quality Management System in accordance with FDA requirements, FDA QMSR, ISO 13485, and other medical device standards.
• Manage quality documentation, document control, training records, change control, nonconformance processes, and CAPA activities.
• Maintain QMS processes suited to software-driven products, cloud infrastructure, CI, DevOps, and Agile development.
• Partner with development team to maintain traceability linking user stories, software requirements, hazard analyses, and V&V test cases.
• Support global regulatory submissions, product registrations, and ongoing regulatory compliance including FDA 510(k) submissions and EU MDR documentation.
• Assess software patches and product changes for regulatory impact and documentation needs.
• Oversee complaint handling, investigations, and root cause analysis with cross-functional teams.
• Oversee post-market surveillance, adverse event reporting, and supplier quality management.
• Maintain design control, risk management, verification, and validation documentation throughout the product lifecycle.
• Drive risk management in accordance with ISO 14971 and IEC 62304 compliance.
• Support usability engineering per IEC 62366 and SBOMs/vulnerability management.

Conhecimentos

QMS management

Regulatory affairs

SaMD

FDA 510(k)

ISO 13485

IEC 62304

Risk management

Cybersecurity knowledge

Technical writing

Cross-functional collaboration

Formação académica

Bachelor’s degree in Engineering/Regulatory/Life Sciences

Ferramentas

Cloud deployment

CI/CD

DevOps

Hazard analyses

Descrição da oferta de emprego

Job Description

Quality Systems and Software Development

• Maintain, and continuously improve the Quality Management System in accordance with applicable FDA requirements, FDA QMSR, ISO 13485, and other relevant medical device standards.
• Manage quality documentation, document control, training records, change control, nonconformance processes, and Corrective and Preventive Action (CAPA) activities.
• Maintain QMS processes suited to software-driven products, cloud infrastructure, continuous integration, DevOps workflows, and Agile development.
• Partner with development team to maintain traceability linking user stories, software requirements, hazard analyses, and verification and validation (V&V) test cases.

Regulatory Affairs and Post-Market Compliance

• Support and lead, as appropriate, global regulatory submissions, product registrations, and ongoing regulatory compliance, including FDA 510(k) submissions, EU MDR Technical Files, and international registrations.
• Assess software patches, feature releases, and product changes to determine regulatory impact and appropriate documentation, including internal assessments, letters-to-file, or new submissions where required.
• Monitor changes to applicable regulatory requirements and standards and implement updates to quality and regulatory processes.
• Oversee complaint handling, triage, and technical investigations involving customer complaints, software bugs, and product performance issues; collaborate with Product Support and Engineering to identify root causes.
• Evaluate software anomalies and performance issues against applicable global adverse event reporting requirements, including FDA Medical Device Reporting (MDR) and EU Vigilance, and coordinate timely reporting when required.
• Oversee nonconformance investigations and use post-market feedback to identify trends and drive continuous quality improvement.

Risk Management, Cybersecurity, and Product Quality

• Maintain design control, risk management, verification, and validation documentation throughout the product lifecycle.
• Drive risk management activities in accordance with ISO 14971, including assessment of software anomalies, defects, and deployment regressions during iterative development.
• Support software lifecycle and validation activities consistent with IEC 62304.
• Support usability engineering and human factors activities consistent with IEC 62366, including validation of user interface updates for safe use.
• Maintain applicable cybersecurity documentation, including SBOMs, threat modeling, and vulnerability management plans.

Audits, and Release Quality

• Coordinate internal and external audits and support regulatory inspections, including preparation, follow-up, and corrective actions.
• Define and execute release-quality processes for software and hardware products to ensure applicable specifications and controlled records are met.
• Maintain appropriate release documentation and ensure release decisions are supported by required quality, verification, validation, risk, and regulatory records.
• Collaborate cross-functionally with Engineering, Clinical, Product Management, Operations, and other stakeholders to maintain product quality and regulatory compliance.

Skills and Requirements

Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related technical field.
• 5–8 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Experience with software as a medical device (SaMD), medical device software, and cloud deployment, experience in these areas is strongly preferred.
• Demonstrated experience managing a QMS, supporting audits and regulatory inspections, and maintaining quality and regulatory documentation.
• Experience supporting or leading regulatory submissions, ideally including FDA 510(k) submissions, EU MDR documentation, and international registrations.
• Working knowledge of FDA 21 CFR Part 820 / FDA QMSR, ISO 13485, ISO 14971, CAPA, design controls, and software lifecycle practices such as IEC 62304.
• Knowledge of medical device software lifecycle and validation principles, including IEC 62304, and familiarity with usability engineering under IEC 62366.
• Understanding of post-market surveillance, complaint investigations, adverse event reporting, and supplier quality management.
• Familiarity with software cybersecurity documentation, such as SBOMs, threat modeling, and vulnerability management, is preferred.
• Strong technical writing, analytical, organizational, communication, and problem-solving skills.
• Ability to work independently, manage competing priorities, and collaborate effectively across technical and business teams.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].