Why Join Bracco Medical Technologies?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!
The Sr. Principal Regulatory Affairs Specialist is responsible for independently developing, implementing, and defending complex global regulatory strategies across products, programs, and processes. This individual serves as a senior regulatory subject matter expert and strategic partner to project teams and leadership, aligning cross-functional stakeholders around regulatory strategies that support business objectives and successful market access.
This role leads regulatory activities for complex new product development and lifecycle programs, including the preparation and management of global regulatory submissions. The individual serves as a primary BMT representative in interactions with U.S. and international regulatory authorities and Notified Bodies, including independently developing FDA Pre-Submission strategies and meeting packages, leading regulatory authority meetings, presenting and defending BMT positions, and driving responses and follow-up actions.
This individual provides technical leadership and mentorship across Regulatory Affairs, drives regulatory excellence and continuous improvement, and leverages approved digital, automation, and generative AI tools to improve the quality, consistency, efficiency, and predictability of regulatory deliverables while maintaining appropriate human oversight and accountability for the final work product. Primary Duties & Responsibilities:
Independently develop, align, execute, and defend complex global regulatory strategies for new products, significant product changes, and lifecycle programs, including identification of regulatory requirements, applicable standards, regulatory risks, decision points, evidence requirements, and contingency strategies.
Complete regulatory assessments and provide strategic regulatory guidance on the interpretation and application of applicable standards, guidance documents, regulations, and laws to support product development, product modifications, and regulatory submissions.
Complete regulatory assessments and provide strategic regulatory guidance to project teams supporting new product development and product modifications.
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Lead complex global regulatory submission programs, including planning, authoring, documentation management, cross-functional coordination, issue resolution, submission readiness, authority responses, approval activities, and maintenance of project status, milestones, and key deliverables.
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Lead regulatory activities associated with field corrective actions as necessary to maintain compliance.
Review device labeling in all forms and advertising materials for compliance with FDA submissions and applicable regulations; analyze and recommend appropriate changes.
Lead regulatory authority engagement strategies, including FDA Q-Submissions and Pre-Submissions; develop and drive preparation of meeting packages, align cross-functional stakeholders, lead regulatory authority interactions and meetings, interpret feedback, and ensure execution of resulting actions and commitments.
Lead audit and inspection preparedness efforts across assigned programs and product lines; represent BMT during FDA, Notified Body, Health Authority, and other external audits and inspections, including strategy development, direct regulator interactions, observation response support, and corrective action follow-through.
Establish and maintain productive relationships with regulatory authorities, Notified Bodies, third-party reviewers, testing laboratories, external consultants, and industry experts to support regulatory strategy, submissions, issue resolution, and successful regulatory outcomes.
Provide technical leadership,…