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Bracco Medical Technologies · 6 hours ago

Principal Regulatory Affairs Specialist

Twin Cities Area

Full-time

Hybrid

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 projects and products. This role involves providing regulatory support for new product submissions, ensuring compliance with regulations, and mentoring junior staff.

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, 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

Qualification

Regulatory Affairs510(k) submissionsEU MDRHealth Canada submissionsRAC CertificationFDA regulationsInternational submissionsTechnical writingAnalytical skillsPlanning skillsCommunication skillsProblem-solvingOrganizational skills

Required

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

Preferred

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 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

Benefits

Paid Time Off, Company Holidays & Paid Family Leave

Annual incentive plan and 401k savings plan contributions

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.

Structured on-the-job learning, workshops, seminars, and our tuition reimbursement program