Senior RA/QA Leader, Surgical Robotics

Sysmex America, Inc.; Lincolnshire (IL); On-site; USD 126,000 - 175,000; Full time

Benefits offered by this job

Health care plan

Annual incentive bonus

Paid time off

Parental leave

Bereavement leave

401(k)

Job summary

Sysmex America, Inc. in Lincolnshire, Illinois, seeks a Sr Manager of Regulatory Affairs & Quality Assurance for Surgical Robotics. You will lead regulatory strategy, prepare submissions, and interface with FDA and Health Canada, reporting to the Sr. Director, Regulatory Affairs.

You will guide cross‑functional teams on design, development, and marketing, ensure compliance, and drive continuous improvements in RA/QA programs within a dynamic, global diagnostics company.

Qualifications

• Bachelor’s degree in science or equivalent experience is required.
• Regulatory knowledge and experience in medical devices, including FDA/Health Canada
• Experience with regulatory agency interactions and submissions is essential.
• Familiarity with 510(k) and Canada MDL processes, and relevant medical device standards.

Responsibilities

• Lead preparation, documentation and submission of FDA and Health Canada applications and responses.
• Maintain device establishments registrations and license renewals per FDA/Health Canada requirements.
• Review regulatory materials for accuracy and align with strategies.
• Provide regulatory guidance to cross-functional teams on design, development and marketing.
• Support audits (ISO and regulatory bodies) and continuous improvement of RA/QA processes.
• Maintain knowledge of applicable regulations and post-market surveillance activities.

Skills

Regulatory affairs

RAC certification

Regulatory liaison

FDA/Health Canada knowledge

510(k) process

Canada MDL process

Medical device standards

Surgical robotics

PMP certification

Japanese language

IT skills

Scientific communication

Stakeholder management

RA/QA experience

Organization

Team leadership

Microsoft Office

Adobe

Education

Bachelor’s degree in science

Tools

Microsoft Office

Adobe

Job description

Sysmex America, Inc. in Lincolnshire, Illinois, seeks a Sr Manager of Regulatory Affairs & Quality Assurance for Surgical Robotics. You will lead regulatory strategy, prepare submissions, and interface with FDA and Health Canada, reporting to the Sr. Director, Regulatory Affairs.

You will guide cross‑functional teams on design, development, and marketing, ensure compliance, and drive continuous improvements in RA/QA programs within a dynamic, global diagnostics company.