Regulatory Affairs Specialist (FDA medical device regulation) - REMOTE: Anywhere USA

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

Job Description

Duties and 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 reputed company (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 reputed company 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. reputed company (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 environmentorRegulatory 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 reputed company at all levels of reputed company (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 position requires the ability to perform the following physical demands and/or have the listed capabilities:

• The ability to sit up 75-100% of applicable work tim

Apply To This Job