Principal Regulatory Affairs Specialist

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.

• 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.

• 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

• 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
• 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…