Principal Regulatory Affairs Specialist

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!

• 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, provide strategic regulatory direction and communicate global regulatory requirements and strategy to project teams and cross-functional partners.
• Review, edit and approve project documentation as the active regulatory representative on project teams.
• 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.
• Maintain all regulatory files ensuring documentation and registrations are complete and up to date.
• Mentor, develop, and provide oversight of junior regulatory staff and provide training and guidance for cross-functional partners.
• 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.

• Bachelor's degree
• Minimum of 7+ years of experience in Regulatory Affairs
• Minimum of 6 years medical device industry experience including strong 510(k) submission experience, 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
• Effective written and verbal communication skills, technical writing and editing skills necessary for high-quality regulatory submission documents
• Proven track record of successfully leading FDA meetings, such as pre-submissions and submission issue request meetings
• Ability to develop clear, concise, and timely oral and written reports
• Ability to communicate complex information and regulatory decisions tactfully to all levels of personnel
• Ability to explain technical materials concisely to audiences of varying degrees of familiarity
• Ability to solve complex problems through the application of critical thinking skills
• Effective research and analytical skills
• 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
• 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
• Works effectively in a matrixed environment and influences internal partners to achieve desired business outcomes
• Serves as role model and embraces corporate values and behaviors
• Meets individual goals as defined in the annual objectives.
• Ability to assess and recommend alternatives to ensure compliance with standards and regulations
• Knowledge of medical terminology

• 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
• Strong FDA, Health Canada, TGA, and EU submission experience, including EU MDR
• International regulatory submission experience, including Japan and China

• 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
• Travel requirements are minimal. Travel up to 1-2 times annually for 2-3 days duration each trip

Estimated Starting Salary Range: $131,000 - $143,000

Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range…