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Bracco Medical Technologies · 1 week ago

Principal Regulatory Affairs Specialist

Twin Cities Area

Full-time

Onsite

Senior Level, Lead/Staff

$131K/yr - $143K/yr

7+ years exp

Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist responsible for developing and implementing regulatory strategies across various projects and products. The role involves collaborating with internal stakeholders and external consultants to ensure compliance with regulations and maintain product approvals.

ManufacturingMedicalMedical Device

Comp. & Benefits

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, assess potential impact(s), and recommend alternatives to ensure compliance with all standards and regulations

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 oversight of junior regulatory staff and provide training and guidance for cross-functional partners

Qualification

Regulatory Affairs510(k) submissionsEU MDR complianceFDA interactionsRAC CertificationTechnical writingCritical thinkingCommunication skillsOrganizational skillsMentoring

Required

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