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Regulatory Affairs Specialist

4 weeks ago

StocktononTees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

Job Summary

Fujifilm Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for the company's medical device regulatory requirements. The successful candidate will be responsible for ensuring full compliance with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulations, ISO 13485 standard requirements, and other applicable laws and standards.

Key Responsibilities

  • Designated Responsible Personnel for Device Marketing Authorization and Facility Registration
  • Perform Pre-Market U.S. FDA submissions (510(k) and PMA)
  • Provide feedback and recommendations to design teams regarding 510(k) submissions
  • Prepare European Union Technical Files and International Regulatory Submissions
  • Coordinate Import/Export/Customs activities
  • Evaluate customer complaints and determine Medical Device Reportability
  • Coordinate Mandatory Field Notifications, Engineering Change Orders, and Correction and Removals
  • Interact with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs, and Sales teams
  • Perform Corrective and Preventive Action activities
  • Prepare documentation for remediation activities
  • Prepare Management Review Meeting presentations

Requirements

  • Bachelor's degree highly preferred
  • Three (3) or more years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment
  • Broad knowledge of U.S. FDA medical device regulations and international medical device standard requirements
  • Excellent leadership, communication, collaboration, team work, and interpersonal skills
  • Strong ability to effectively communicate with staff members and business partners at all levels of the organization
  • Excellent computer and internet search skills
  • Strong ability to multi-task and meet business deadlines
  • Excellent organizational skills with an ability to think proactively and prioritize work

Physical Requirements

  • The ability to sit up 75-100% of applicable work time
  • The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time
  • The ability to stand, talk, and hear for 75% of applicable work time
  • The ability to lift and carry up to ten pounds up to 20% of applicable work time
  • Close Vision: The ability to see clearly at twenty inches or less

Travel

  • Occasional (up to 25%) travel may be required based on business need