Regulatory Affairs Specialist – FDA Medical Device Regulation

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

FUJIFILM Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1934

Healthcare • Electronics • Imaging

FUJIFILM Corporation is a global company established in 1934, operating in diverse fields including healthcare, electronics, and imaging. As a total healthcare company, FUJIFILM develops a wide range of businesses in prevention, diagnosis, and treatment. Additionally, the company focuses on environmental sustainability through improved industrial efficiency, while also capturing and preserving memories through film and photography, enriching emotional lives and human connections.

📋 Description

• 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. • Prepare European Union Technical Documentation and International Regulatory Submissions. • Evaluate all sources of incoming customer information, identify, investigate, and document escalated Customer Complaints. • Confirm the Medical Device Reportability of identified potential adverse events. • Coordinate Field Action Notifications, Risk Assessments, and Correction and Removals. • Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales.

🎯 Requirements

• Bachelor's degree in related discipline and 2+ years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment or Regulatory Affairs Certification and 4+ 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 (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations. • Broad knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations). • Excellent leadership, communication, collaboration, team work and interpersonal skills. • Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external). • Excellent computer and internet search skills. • Strong ability to multi-task and to meet business deadlines. • Excellent organizational skills with an ability to think proactively and prioritize work.

🏖️ Benefits

• Health insurance • 401(k) matching • Remote work options