[Hiring] Regulatory Affairs Specialist @Fujifilm

Role Description

This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation. This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Duties and Responsibilities

• Designated Responsible Personnel for Device Marketing Authorization and Facility Registration.
• Designated Joint Responsibility pursuant of Article 15 of the European Union Medical Device Regulation (EU MDR (EU) No. 2017/745).
• 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 deciding when to submit a 510(k) for a change to an existing medical device.
• Provide feedback and communicate the conclusion to business units regarding regulatory documentation of new product and supplier assessment.
• 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.
• Confirm the Medical Device Reportability of identified potential adverse events, take appropriate action and maintain all records.
• Coordinate Field Action Notifications, Risk Assessments, and Correction and Removals, take appropriate action and maintain all records.
• Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action.
• Perform Corrective and Preventive Action activities.
• Prepare QMS audit data.
• Prepare documentation for remediation activities.
• Support Import/Export/Customs activities.
• Prepare Management Review Meeting data.
• Attend all department and company-wide team meetings as needed.
• Other duties as assigned.
• Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Qualifications

• 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.

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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected] or (330) 425-1313).