Principal Regulatory Affairs Specialist

Bracco Medical Technologies•Eden Prairie, MN

2d•$131,000 - $142,000•Hybrid

About The Position

The Principal Regulatory Affairs Specialist is responsible for developing and implementing regulatory strategies across projects, processes, and/or products. This individual partners with internal stakeholders and external consultants to optimize and execute these strategies in support of business objectives. This role provides hands-on regulatory affairs support for new product marketing submissions and changes to existing devices, including development of regulatory requirements/strategies and preparing submissions. In addition, this individual will represent BMT Regulatory in interactions with US and international regulators during submission reviews/approvals and audits. This individual will ensure compliance with required regulations and established corporate standards and ensure that product approvals are properly maintained. This position requires creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks to drive successful outcomes. This individual serves as a regulatory subject matter expert and strategic partner, leveraging regulatory expertise, digital technologies, and AI tools to support efficient, high-quality regulatory outcomes.

Requirements

Bachelor’s degree plus 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 framework including how to comply with standards and regulations
Experience successfully leading FDA meetings, such as pre-submissions and submission issue request meetings
Effective written and verbal communication skills, technical writing and editing skills.
Ability to develop clear, concise, and timely oral and written reports, and communicate complex information and regulatory decisions tactfully and concisely to all levels of audiences with varying degrees of familiarity
Ability to solve complex problems through the application of critical thinking skills
Demonstrated proficiency using approved digital productivity and generative AI tools (e.g., Microsoft 365 Copilot or equivalent) to support document development, data analysis, research, communication, and process efficiency while maintaining appropriate human oversight and accountability for final work product.
Requires high concentration and attention to detail to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to internal processes, policies, procedures and other quality-related documentation, which may involve point-by-point comparisons
The work is detail oriented, often with multiple or competing priorities
The environment is deadline sensitive, with frequent high-pressure situations

Nice To Haves

RAC Certification
Bachelor’s degree in science, engineering or related technical discipline
10+ years or greater of experience in the medical device industry
10+ years or greater working in Regulatory Affairs
Advanced level of 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 desired business outcomes
Experience evaluating regulatory considerations associated with software-enabled, connected, cybersecurity-focused, artificial intelligence (AI), and machine learning-enabled medical devices.

Responsibilities

Develop and execute regulatory plans and author 510(k) Premarket Notifications, EU MDR Technical Documentation, Canadian Licensing Submissions, and contribute content to Japan and China submissions.
Coordinate cross-functional support for worldwide registrations for global product growth and market expansion.
Participate as 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 / 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 potential business and regulatory impact, communicate changes to stakeholders; recommend strategies to ensure compliance and support business objectives.
Contribute content for and review all forms of device labeling and advertising materials for compliance with FDA submissions and applicable global regulations; analyze and recommend appropriate changes.
Serve as the primary point of contact with external regulatory consultants, when applicable, coordinating their contributions and ensuring alignment with internal regulatory strategies and timelines.
Maintain all regulatory files ensuring documentation and registrations are complete and up to date.
Demonstrates strong planning, organizational and time management skills, including the ability to work on multiple projects and adhere to timelines to achieve desired outcomes
Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments
Commits to driving efficiency while maintaining quality, and ensures timely, clear communications to internal stakeholders on project status and issues
Supports the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks
Mentor, develop, and provide technical leadership to junior regulatory staff; promote best practices; provide training and regulatory guidance to cross-functional partners.
Leverage digital, automation, and generative AI tools to improve the efficiency, quality, consistency, and predictability of regulatory deliverables while ensuring compliance with company policies, confidentiality requirements, and applicable regulations.
Drive continuous improvement initiatives that enhance regulatory processes, document quality, submission readiness, inspection preparedness, and operational efficiency.