Regulatory Affairs Specialist – FDA Medical Device Regulation

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support in Regulatory Affairs for FUJIFILM Healthcare Americas Corporation.

• Ensure continuous compliance with all relevant U.S. Food and Drug Administration (U.S. FDA) medical device regulatory standards.

• Act as the Designated Responsible Personnel for Device Marketing Authorization and Facility Registration.

• Conduct Pre-Market U.S. FDA submissions (510(k) and PMA) in line with the product strategy.

• Offer insights and recommendations to design teams on the appropriate timing for submitting a 510(k) for modifications to existing medical devices.

• Prepare Technical Documentation for the European Union and manage International Regulatory Submissions.

• Assess all incoming customer information, identify, investigate, and document escalated Customer Complaints, conduct trend analysis, and maintain comprehensive records.

• Manage Field Action Notifications, Risk Assessments, and Corrections and Removals.

⛳️ Requirements

• A Bachelor’s degree in a relevant field.

• A minimum of 2 years of practical experience in Regulatory Affairs support activities within a U.S. FDA regulated setting, or a Regulatory Affairs Certification coupled with 4+ years of relevant experience.

• Extensive understanding of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) as well as U.S. FDA import/export/customs regulations.

• Comprehensive knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive, and Canada Medical Device Regulations).

• Proficient computer skills and adept at internet research.

• Strong multitasking abilities and capability to meet business deadlines.

• Exceptional organizational skills with a proactive mindset and the ability to prioritize tasks effectively.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.