Hybrid Senior Manager, Regulatory Affairs
On-siteLincolnshire, Illinois, United States
Job Summary
Lead regulatory strategy for new and modified medical device products, preparing, documenting, and submitting FDA and Health Canada applications while responding to agency inquiries. Manage device establishment registrations, listings, and licensing renewals, and review all regulatory materials for accuracy and compliance with standards. Provide regulatory guidance to cross-functional teams on design, development, evaluation, and marketing strategies, and oversee post-approval change evaluations. Set team objectives to align with business and regulatory strategies, maintaining current knowledge of relevant regulations including those for IVD products. Lead development of regulatory strategies that meet requirements and support planned changes. Minimal travel required (5-10%).
Required 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
- Excellent communication, organizational skills, and the ability to handle high-stress situations
- Proficiency in English is required
- 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.
Desired Qualifications
- Experience in Hematology, Urinalysis, Flow Cytometry, and Coagulation is a plus
- RAC and PMP qualifications would be advantageous
- Japanese would be a plus
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