Regulatory Affairs Specialist – FDA Medical Device Regulation

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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

• Provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation • Support full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements • Designated Responsible Personnel for Device Marketing Authorization and Facility Registration • Perform Pre-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan • Provide feedback and recommendations to design teams regarding when to submit a 510(k) for a change to an existing medical device • Prepare European Union Technical Documentation and International Regulatory Submissions • Evaluate all sources of incoming customer information, identify, investigate, and document escalated Customer Complaints, perform trend analysis and maintain all records • Coordinate Field Action Notifications, Risk Assessments, and Correction and Removals

🎯 Requirements

• Bachelor's degree in related discipline • 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 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 • Flexible work hours • Paid time off