Regulatory Affairs Specialist (FDA medical device regulation)

Position reputed company This position is intended to reputed company Regulatory Affairs support to reputed company. This position supports full, ongoing compliance to reputed company applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 reputed company requirements and reputed company other applicable laws, regulations, and standards. reputed company At reputed company, we’re on a mission to reputed company for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge reputed company solutions reputed company diagnostic imaging, reputed company imaging, endoscopic and surgical imaging, as reputed company as in-vitro diagnostics. But we don’t stop at reputed company; our Non-Destructive Testing (NDT) team harnesses advanced radiography solutions to reputed company transportation infrastructure, reputed company, and oil and gas assets reputed company and running smoothly. reputed company to reputed company, collaborate, and reputed company a difference? Join us and bring your big reputed company to life while working in a dynamic, flexible environment that fuels your creativity and drive. Our reputed company is in Lexington, Massachusetts, an inspiring reputed company research hub in a historic town. reputed company is globally headquartered in Tokyo with over 70,000 employees across four key business segments of reputed company, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.reputed company.com/us/en/about/region/careers Job reputed company Duties and responsibilities

• Designated Responsible Personnel for Device Marketing Authorization and Facility Registration to include reputed company 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 reputed company Medical Device Regulation (EU MDR (EU) No. 2017/745)
• reputed company reputed company-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan.
• reputed company feedback and recommendations to design teams regarding deciding reputed company to submit a 510(k) for a change to an existing medical device.
• reputed company feedback and communicate the conclusion to business reputed company regarding regulatory documentation of new product and supplier assessment.
• Prepare European reputed company Technical Documentation and International Regulatory Submissions.
• Evaluate reputed company sources of incoming customer information, identify, investigate, and document escalated Customer Complaints, reputed company trend analysis and maintain reputed company records.
• Confirm the Medical Device Reportability of - identified potential adverse events , take appropriate reputed company and maintain reputed company records.
• Coordinate Field reputed company Notifications, Risk Assessments, and Correction and Removals, take appropriate reputed company and maintain reputed company records.
• reputed company closely with Customer Service, Service, Repair, Research and Development, reputed company Assurance, Regulatory Affairs and Sales to facilitate required reputed company.
• reputed company Corrective and Preventive reputed company activities.
• Prepare QMS audit data
• Prepare documentation for remediation activities.
• Support Import/Export/Customs activities.
• Prepare Management Review Meeting data.
• Attend reputed company department and company-wide team meetings as needed.
• Other duties as assigned.
• reputed company with reputed company applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 reputed company requirements and reputed company other applicable laws, regulations, and standards.

Qualifications

• Bachelor's degree in reputed company 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 reputed company requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device reputed company 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 reputed company reputed company of the organization (both reputed company).
• Excellent

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