Regulatory Affairs Manager - Chicago, United States - Catalyst Life Sciences

Description

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements.

While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

Main Responsibilities

• Lead the US & Canada Regulatory team to prepare the documentation and submissions for FDA and Health Canada, as well as the responses to regulatory agencies.
• Manage the maintenance of device registrations and ongoing compliance activities.
• Responsible for the ongoing reviewing of regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards.

Experience Required

• 6 years' Regulatory Affairs experience within Medical Devices or IVDs, understanding FDA requirements for 510(k)s and 21 CFR 820.
• Prior management or team leadership experience.
• Experience working directly with regulatory agency representatives.
• This is a hybrid role that requires at least 3 days a week onsite in Chicago, IL.