Senior Regulatory Affairs & QA Lead - Surgical Robotics

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

Ventajas ofrecidas por este puesto de trabajo

Health care plan

Annual incentive bonus

Paid time off

Parental leave

401(k)

Descripción de la vacante

Sysmex Corporation in Lincolnshire, IL, leads a strategic regulatory affairs and quality assurance role for Surgical Robotics. This Senior Manager will guide regulatory strategy for new and modified products and interface with FDA and Health Canada, reporting to the Sr.

Director, Regulatory Affairs. Ideal candidates have 7+ years in medical device RA/QA, strong communication, and cross-functional leadership.

Formación

• Bachelor’s degree in science-related field or equivalent experience.
• Minimum 7+ years of progressive experience in medical device regulatory affairs.
• Experience interacting with regulatory agency representatives.
• Thorough understanding of FDA/Health Canada requirements for medical devices (21 CFR 820, ISO 13485, ISO 14971).
• Knowledge of 510(k) and Canada MDL processes.
• English required; Japanese would be a plus.
• Strong communication and stakeholder management skills.

Responsabilidades

• Lead preparation, documentation and submission of FDA/Health Canada applications.
• Manage device establishment registrations, listings and licensing renewals.
• Review regulatory materials for accuracy and compliance.
• Provide regulatory guidance to cross-functional teams.
• Maintain regulatory knowledge of current rules.
• Develop regulatory strategies for planned changes.
• Support internal and external audits (ISO/regulatory).
• Support maintenance and improvement of the quality system (ISO).
• Conduct post-market surveillance and post-approval activities.
• Other duties as assigned.

Conocimientos

Regulatory Affairs

Quality Assurance

FDA Knowledge

English Proficiency

Communication Skills

Educación

Bachelor’s degree in science-related field

Herramientas

Microsoft Office

Adobe Suite

Descripción del empleo

Sysmex Corporation in Lincolnshire, IL, leads a strategic regulatory affairs and quality assurance role for Surgical Robotics. This Senior Manager will guide regulatory strategy for new and modified products and interface with FDA and Health Canada, reporting to the Sr.

Director, Regulatory Affairs. Ideal candidates have 7+ years in medical device RA/QA, strong communication, and cross-functional leadership.