Principal Regulatory Affairs Specialist

Bracco Medical Technologies•Eden Prairie, MN

1d•$132,000 - $160,000

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 and approvals, as well as audits, and helps ensure regulatory compliance and maintenance of product approvals. The position requires independent research, sound regulatory judgment, innovation, and the ability to serve as a regulatory subject matter expert and strategic partner. It also involves using digital technologies and AI tools to support efficient, high-quality regulatory outcomes. The specialist leads regulatory planning and submission work, coordinates worldwide product registrations, and participates on project teams throughout the product lifecycle. They provide regulatory direction, review and approve documentation, communicate regulatory requirements, engage with agencies and Notified Bodies, monitor evolving regulations and standards, and help ensure labeling and advertising materials comply with applicable requirements. The role also maintains regulatory files, coordinates external consultants, mentors junior staff, and drives continuous improvement in regulatory processes, submission readiness, and operational efficiency. The position requires strong planning, organization, time management, communication, and problem-solving skills. The work demands high concentration and attention to detail, often across multiple competing priorities and deadlines, and may involve high-pressure situations. Travel is minimal, with 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 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, timely oral and written reports and communicate complex information and regulatory decisions tactfully to audiences with varying levels of familiarity.
Ability to solve complex problems using critical thinking.
Demonstrated proficiency with 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.
High concentration and attention to detail to assess regulatory compliance and compare requirements with internal processes, policies, procedures, and quality documentation.
Ability to manage detail-oriented work with multiple or competing priorities in a deadline-sensitive environment.

Nice To Haves

RAC Certification.
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.
Represent Regulatory Affairs on project teams throughout the product lifecycle; review, edit, and approve project documentation; provide strategic regulatory direction and communicate global requirements and strategies.
Communicate with government regulatory agencies and Notified Bodies, prepare for and lead meetings and teleconferences with external authorities including the FDA, and support audits and inspections as assigned.
Identify emerging regulations, guidance documents, standards, and industry trends; assess business and regulatory impact, communicate changes, and recommend compliance strategies.
Contribute to and review device labeling and advertising materials for compliance with FDA submissions and applicable global regulations, and recommend changes.
Serve as the primary contact for external regulatory consultants when applicable, coordinating their work and aligning it with internal strategies and timelines.
Maintain complete and up-to-date regulatory files and registrations.
Plan and organize work across multiple projects, manage priorities and timelines, take initiative, and hold self and others accountable for commitments.
Promote efficiency while maintaining quality, communicate project status and issues clearly and promptly, and proactively manage issues, 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.
Use approved digital, automation, and generative AI tools to improve regulatory deliverable efficiency, quality, consistency, and predictability while complying with company policies, confidentiality requirements, and regulations.
Drive continuous improvement in regulatory processes, document quality, submission readiness, inspection preparedness, and operational efficiency.