New · posted Oct 15
Sysmex America · Medical Devices
Sr Manager, Regulatory Affairs & Quality Assurance – Surgical Robotics
- Lincolnshire, IL
- On-site
- Full-time
- Manager
Closes Sep 1, 2027 · 321 days left
The role
Find a Better Way... ...to use your skills and experience.This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way....to improve the lives of others.Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory....to build a promising future.
What you need
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.
The salary range for this role is $126,000-$175,000. Within this range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.
What you'll do
We currently have a great opportunity for a Sr Manager, Regulatory Affairs & Quality Assurance – Surgical Robotics. The Senior Manager position in Regulatory Affairs and Quality Assurance leads the regulatory strategy for new and modified Surgical Robotics products. The individual will lead, assess and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities in the US & Canada. The individual is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications. The individual may have the opportunity to manage team members and will report to the Sr. Director, Regulatory Affairs.
1. Leads preparation, documentation and submission of FDA and Health Canada applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes2. 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.3. Review all regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards and set team objectives to ensure alignment with business and regulatory strategies.4. Provide regulatory guidance and leadership to cross-functional departments or development project teams regarding design, development, evaluation, or marketing (ad/promo) of products.5. 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.6. Maintain current knowledge of relevant regulations and guidelines both proposed and final rules including those for medical devices products. 7. Manages & leads development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.8. Support internal and external audits, including ISO and/or regulatory body audits.9. Support the maintenance and continuous improvement of the quality management system to ensure ongoing compliance with applicable ISO standards and regulatory requirements.10. Conduct post-market surveillance activities and support post-approval products through change evaluation and submission and annual reporting as required. Other duties as assigned.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Pay and benefits
$126,000 – $175,000 a year
Employer providedHealth care plan (medical, vision, dental)
Annual incentive bonus
Paid time off
Parental leave
Bereavement leave
401(k)
Where you'll work
Lincolnshire, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in Lincolnshire, ILWorking conditions
Travel Percentage: <25%
Physical Risk: No unusual exposures to risk.
Equal opportunity, accessibility and legal noticesSysmex America's statements, word for word
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $126,000 | — | $175,000 |
| All US (middle half) | $146,750 | $162,500 | $177,750 |
This role: Sysmex America's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Sysmex America's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Regulatory submissions6
- GMP and compliance2
- Documentation and SOPs2
- Quality systems and risk2
- Data and digital systems2
- Lab testing and methods1
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
Company hiring pulse
Sysmex America on Regulatory Jobs
- 1
- Open roles
- 1
- Distinct roles
- 1
- Locations
Similar Regulatory Affairs roles elsewhere
- View role
Manager, Regulatory Affairs
BaxterDeerfield, IL · HybridManagerMedical Devices$120K–$165K
- View role
Sr Mgr, Regulatory Affairs
BaxterDeerfield, IL · HybridManagerMedical Devices$152K–$209K
- View role
Manager, Regulatory Affairs
iRhythmRemote, USManagerMedical Devices$127K–$165K
- View role
Senior Regulatory Affairs Manager
QuidelOrthoRemote, USManagerMedical Devices$150K–$170K
Sr Manager, Regulatory Affairs & Quality Assurance – Surgical Robotics at Sysmex America
Applications close September 1. $126K–$175K a year, employer provided.