Sr. Principal Regulatory Affairs Specialist - Bracco Medical Technologies

Bracco•Eden Prairie, MN

1d•Hybrid

About The Position

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.

Requirements

Minimum Bachelor’s degree plus 15 years of progressively responsible regulatory experience, including at least 10 years in the medical-device industry.
Strong working knowledge and experience with quality systems regulations and guidelines, ISO, GMP, FDA, Medical Device Directive (EU MDD and MDR), international regulatory requirements, risk management, and product development processes
Strong submission experience, including FDA 510(k) or PMA, EU CE Mark submissions (MDD and MDR), Health Canada submissions, and international market submissions including Japan and China
Excellent written, verbal, technical writing, and presentation skills, with the ability to communicate complex regulatory and technical information clearly and effectively to audiences at all organizational levels.
Strong research, analytical, critical-thinking, and problem-solving skills, including the ability to develop practical and compliant solutions to complex regulatory challenges.
Demonstrated ability to lead complex projects, influence cross-functional stakeholders, manage competing priorities, proactively mitigate risks, and deliver high-quality results in a matrixed environment.
Serves as role model and embraces corporate Values and Behaviors
Knowledge of medical terminology
Demonstrated experience developing and executing complex global regulatory strategies and leading major medical device submissions, including FDA, EU MDR, Health Canada, and international market registrations.
Experience leading regulatory authority and Notified Body interactions, including FDA Pre-Submissions/Q-Submissions, Structured Dialogue, development of meeting packages, and facilitation of health authority meetings.
Demonstrated ability to lead through influence, develop productive relationships with regulatory authorities and external stakeholders, and effectively leverage approved digital and generative AI tools to improve regulatory outcomes while maintaining accountability for final decisions and deliverables.
Requires intense concentration in order to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to processes, policies, procedures and other quality related documentation, which may involve point-by-point comparisons
The work is detail oriented, often with multiple priorities
The environment is deadline sensitive.
Frequent high-pressure situations
Requires strong interpersonal skills

Nice To Haves

RAC Certification
Advanced degree in Science, Engineering or related technical discipline
Experience leading high-profile, complex, or precedent-setting FDA interactions.
Experience with FDA Pre-Submissions involving novel technologies, software, cybersecurity, human factors, clinical evidence, or AI-enabled medical-device functions.
Experience establishing regulatory best practices, mentoring senior regulatory professionals, or leading regulatory process transformation.
Experience evaluating regulatory considerations for software-enabled, connected, cybersecurity-focused, artificial intelligence, or machine learning-enabled medical devices.
Experience developing or implementing AI-enabled regulatory workflows, document-review practices, regulatory intelligence tools, or submission-quality processes.
Experience leading regulatory due diligence and integration activities associated with mergers, acquisitions, licensing agreements, or strategic business development initiatives.

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.
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.
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, mentorship, and strategic regulatory guidance across multiple programs, influencing cross-functional decisions and driving successful regulatory and business outcomes.
Drive continuous improvement through effective use of approved digital, automation, and generative AI technologies to enhance the quality, efficiency, consistency, and predictability of regulatory deliverables while maintaining accountability for final outputs.
Support mergers, acquisitions, licensing, and strategic business initiatives by providing regulatory due diligence, assessing regulatory risks and opportunities, and leading integration activities associated with acquired products, technologies, regulatory processes, and registrations.