Principal Regulatory Affairs Specialist

Bracco•Eden Prairie, MN

About The Position

The Principal Regulatory Affairs Specialist develops and implements regulatory strategies across projects, processes, and products, partnering with internal stakeholders and external consultants to support business objectives. The role provides hands-on regulatory support for new product marketing submissions and changes to existing medical devices, including defining regulatory requirements and strategies and preparing submissions. The specialist represents Bracco Medical Technologies in interactions with U.S. and international regulators during submission reviews, approvals, audits, and inspections, and helps ensure regulatory compliance and maintenance of product approvals. The position requires independent research, creativity, and sound application of regulatory practices. As a regulatory subject matter expert and strategic partner, the specialist uses regulatory expertise and approved digital, automation, and generative AI tools to improve the efficiency, quality, consistency, and predictability of regulatory work, while maintaining appropriate human oversight and complying with company policies, confidentiality requirements, and applicable regulations. The specialist also drives continuous improvement in regulatory processes, document quality, submission readiness, inspection preparedness, and operational efficiency, and provides technical leadership and mentoring to junior staff and cross-functional partners. The work is detail-oriented and deadline-sensitive, often involving multiple or competing priorities and high-pressure situations. Travel is minimal, with travel of up to one or two trips annually, each lasting two to three days.

Requirements

Bachelor’s degree and at least 7 years of experience in medical device Regulatory Affairs.
Demonstrated experience with 510(k), EU CE Marking, and Health Canada submissions.
Understanding of FDA, EU MDD and MDR, Australia, and Canada regulatory frameworks, including compliance with applicable standards and regulations.
Experience successfully leading FDA meetings, such as pre-submissions and submission issue request meetings.
Effective written and verbal communication, technical writing, and editing skills.
Ability to prepare clear, concise, and timely oral and written reports and communicate complex information and regulatory decisions tactfully and concisely to audiences at all levels.
Ability to solve complex problems using critical-thinking skills.
Proficiency using approved digital productivity and generative AI tools, such as Microsoft 365 Copilot or equivalent, for document development, data analysis, research, communication, and process efficiency, with appropriate human oversight and accountability for final work.

Nice To Haves

Regulatory Affairs Certification (RAC).
Bachelor’s degree in science, engineering, or a related technical discipline.
10 or more years of experience in the medical device industry.
10 or more years of experience working in Regulatory Affairs.
Advanced FDA, Health Canada, TGA, and EU submission experience, including EU MDR.
International regulatory submission experience, including Japan and China.
Ability to work effectively in a matrixed environment and influence internal partners to achieve business outcomes.
Experience evaluating regulatory considerations for software-enabled, connected, cybersecurity-focused, artificial intelligence-enabled, and machine-learning-enabled medical devices.

Responsibilities

Develop and execute regulatory plans and author 510(k) Premarket Notifications, EU MDR Technical Documentation, and Canadian licensing submissions; contribute content to Japan and China submissions.
Coordinate cross-functional support for worldwide registrations to support global product growth and market expansion.
Participate as the regulatory representative on project teams throughout the product lifecycle.
Review, edit, and approve project documentation; provide strategic regulatory direction; and communicate global regulatory requirements and strategy to project teams and cross-functional partners.
Communicate with government regulatory agencies and Notified Bodies; prepare for and lead meetings and teleconferences with external regulatory authorities, including the FDA; and support audits and inspections as assigned.
Identify new and emerging regulations, guidance documents, standards, and industry trends; assess their potential business and regulatory impact; communicate changes to stakeholders; and recommend compliance strategies that support business objectives.
Contribute to and review device labeling and advertising materials for compliance with FDA submissions and applicable global regulations, and recommend appropriate changes.
Serve as the primary contact for external regulatory consultants when applicable, coordinating their contributions and ensuring alignment with internal strategies and timelines.
Maintain regulatory files and ensure documentation and registrations are complete and up to date.
Plan and organize work across multiple projects, adhere to timelines, set priorities, take initiative, and hold self and others accountable for commitments.
Drive efficiency while maintaining quality, communicate project status and issues clearly and promptly, manage issues proactively, resolve conflicts, and mitigate risks.
Mentor and develop junior regulatory staff, provide technical leadership, promote best practices, and provide training and regulatory guidance to cross-functional partners.
Leverage approved digital productivity, automation, and generative AI tools to improve regulatory deliverables while following company policies, confidentiality requirements, and applicable regulations.
Drive continuous improvement in regulatory processes, document quality, submission readiness, inspection preparedness, and operational efficiency.