Principal Regulatory Affairs Specialist

Bracco Medical Technologies • Eden Prairie, MN

12d • $131,000 - $143,000

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.

Requirements

• Minimum 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

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

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, 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.

Benefits

• Paid Time Off, Company Holidays & Paid Family Leave – We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
• Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
• Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.
• Choose – You won’t find “stuffy” here—whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees