Hybrid Senior Manager, Regulatory Affairs

Hybrid Senior Manager, Regulatory Affairs - Lincolnshire, Illinois

Introduction:

This is the time to let your talent come to life. Maximize your knowledge and use it for the greater good. Work with top professionals using state-of-the-art technology to improve lives with your innovative ideas and ambitious dreams. Join our team, headquartered in Kobe, Japan, with our operational base in Lincolnshire, Illinois. We are renowned worldwide for the finest quality in innovative diagnostic equipment and information-management systems. Our mission is to apply science to enhance the quality of life globally. Our agile and resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis, and life sciences for the clinical laboratory.

Responsibilities:

We currently have a great opportunity available for a Regulatory Affairs Senior Manager. This role involves leading the regulatory strategy for new and modified medical device products. The Senior Manager will lead, assess, and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities in the US & Canada. Responsibilities include:

Leading the preparation, documentation, and submission of FDA and Health Canada applications and providing responses to regulatory agencies regarding device information or issues.

Managing maintenance of device establishment registrations, listings, and licensing renewals.

Review all regulatory materials for accuracy and compliance with regulatory standards.

Providing regulatory guidance to cross-functional teams on design, development, evaluation, or marketing strategies.

Managing regulatory affairs procedures to maintain or enhance regulatory compliance.

Maintaining current knowledge of relevant regulations, including those for IVD products.

Leading the development of regulatory strategies that meet requirements and provide guidance for planned changes.

Supporting post-approval products through change evaluation and submission.

Setting team objectives to ensure alignment with business and regulatory strategies.

Essential Duties:

Minimal travel required (5-10%).

Other duties as assigned.

Qualifications:

Bachelor's degree in a science-related field or equivalent.

Minimum 7+ years of progressive experience in the medical devices/IVD/biotech industry Regulatory Affairs, including experience with regulatory agencies.

Thorough understanding of FDA, Health Canada regulations, and requirements for in vitro diagnostic devices.

Experience in Hematology, Urinalysis, Flow Cytometry, and Coagulation is a plus.

Excellent communication, organizational skills, and the ability to handle high-stress situations.

Proficiency in English is required; Japanese would be a plus.

Strong IT skills, including Microsoft Office and Adobe.

RAC and PMP qualifications would be advantageous.

COVID-19 Vaccination Policy:

Our vaccination policy requires all employees to be fully vaccinated against COVID-19, consistent with our commitment to providing a safe workplace. Reasonable accommodations are available for medical or religious reasons, provided they do not prevent the performance of job-essential functions.