Regulatory Affairs Specialist (FDA medical device regulation)

Fujifilm•Remote,

1d•Remote

About The Position

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.

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.

Responsibilities

Designated Responsible Personnel for Device Marketing Authorization and Facility Registration to include proper registration, listing, licensing, notification and approval information submission to regulatory authorities or authorized representative participating in the Medical Device Single Audit Program (MDSAP) (ISO 13485/MDSAP)
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.