Regulatory Affairs & QA Leader — Surgical Robotics

Sysmex America; Lincolnshire (IL); Presencial; USD 126.000 - 175.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k)

Annual incentive bonus

Paid time off

Parental leave

Bereavement leave

Descripción de la vacante

Sysmex, headquartered in Kobe, Japan and located in Lincolnshire, Illinois, seeks a Sr Manager of Regulatory Affairs & Quality Assurance for Surgical Robotics. Lead regulatory strategy, submissions and liaison with FDA/Health Canada, guiding cross-functional teams through design, development and marketing activities.

You will steer regulatory plans, ensure compliance with ISO 13485/14971 and 21 CFR 820, and support audits. Prior robotics RA/QA experience plus RAC or PMP are a plus.

Formación

• Bachelor’s degree in science related field or equivalent experience required.
• Minimum 7+ years of progressive experience in medical device industry Regulatory Affairs required.
• RAC would be a plus
• Experience working directly with regulatory agency representatives.
• Thorough understanding of FDA, Health Canada regulations and requirements for medical devices (21 CFR 820, ISO 13485, ISO 14971, CMDR).
• Thorough understanding of the 510(k) process and Canada MDL application process requirements.
• Working knowledge of medical device standards, such as IEC 62304, IEC 60601, IEC 62366, ISO 14155 and applicable usability, software, cybersecurity, and labeling expectations.
• Prior Surgical robotics experience a plus.
• PMP qualification would be a plus.
• English
• Japanese would be a plus
• Excellent general IT skills i.e. Microsoft Office/Outlook, Adobe etc.
• Ability to follow guidelines and effectively communicate scientific data in a structured manner.
• Ability to develop and maintain professional relationships with internal and external subject matter experts to obtain necessary to support product applications or submissions.
• Motivated individual with hands-on RA/QA experience, excellent communication skills, ability to communicate and work at all levels or the organization.
• Strong organizational skills and high attention to detail. Ability to deal with high stress situations is a must.
• Ability to lead & work as part of a team.

Responsabilidades

• Leads preparation, documentation and submission of FDA and Health Canada applications and providing responses to regulatory agencies regarding device information or issues.
• Manages maintenance of device establishment registrations, listings and licensing renewals and ongoing activities for compliance with FDA, Health Canada and other country-specific regulations as required.
• Review all regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards and set team objectives to ensure alignment with business and regulatory strategies.
• Provide regulatory guidance and leadership to cross-functional departments or development project teams regarding design, development, evaluation, or marketing (ad/promo) of products.
• Manages regulatory affairs procedures to make sure that regulatory compliance is sustained or enhanced. Also ensuring adherence to internal procedures. Evaluate and implement continuous improvement in internal processes and procedures.
• Maintain current knowledge of relevant regulations and guidelines both proposed and final rules including those for medical devices products.
• Manages & leads development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.
• Support internal and external audits, including ISO and/or regulatory body audits.
• Support the maintenance and continuous improvement of the quality management system to ensure ongoing compliance with applicable ISO standards and regulatory requirements.
• Conduct post-market surveillance activities and support post-approval products through change evaluation and submission and annual reporting as required.
• Other duties as assigned.

Conocimientos

Regulatory affairs

FDA/Health Canada knowledge

Team leadership

Surgical robotics

PMP

English

Japanese

IT skills

Communication

High attention to detail

Educación

Bachelor’s degree in science related field

RAC

Herramientas

Microsoft Office/Outlook/Adobe

Descripción del empleo

Sysmex, headquartered in Kobe, Japan and located in Lincolnshire, Illinois, seeks a Sr Manager of Regulatory Affairs & Quality Assurance for Surgical Robotics. Lead regulatory strategy, submissions and liaison with FDA/Health Canada, guiding cross-functional teams through design, development and marketing activities.

You will steer regulatory plans, ensure compliance with ISO 13485/14971 and 21 CFR 820, and support audits. Prior robotics RA/QA experience plus RAC or PMP are a plus.