Regulatory Affairs Specialist

Responsibilities

• Prepare & review documentation for internal product registration submissions including the interpretation & preparation of additional information as requested by International governments
• Maintain FDA establishment registration and device listings, including annual laser product reporting
• Maintain Health Canada establishment registration and device listings, including annual reporting
• Participate in FDA inspections & ISO audits
• Maintain knowledge of and ensure compliance to government and industry regulatory requirements
• Interpret and communicate changes to the regulatory requirements, and the impact they have on our current processes
• Maintain product files and product safety test reports to support compliance with regulatory requirements (i.e. UL file maintenance process)
• Maintain current external regulations & standards / compliance (ISO, Health Canada, EU, and JPAL, etc.) and monitoring regulatory environments
• Maintain domestic product registration and submission for the City of Los Angeles
• Prepare, maintain and submit technical files for CE registration
• Communicate the requirements for 510K submittal to appropriate cross functional teams to help facilitate continuous internal process improvement activities assuring compliance to regulatory requirements (i.e. GMP principles, SOP's)
• Oversee the day-to-day activities of company QMS with respect to compliance, documentation preparation and policy deployment
• Review of promotional materials, and labeling for compliance to regulatory requirements
• Write SOPs, Work Instructions and forms to support the QMS, and assuring compliance to regulatory requirements, including recommendations for updates when the regulations or standards change
• Communicate significant issues or developments identifies during quality activities and providing recommendations for process improvements to management
• Host UL FUS & 3 rd party audits (i.e. Truesdail, NSF, Intertek & IAPMO)
• Provide support during new product development, and design changes, on the regulatory requirements, exporting and labeling requirements, and compliance requirements
• Maintain list of approved international dealers, and products that are authorized, and registered, including their expiration dates
• Provide regulatory guidance and support to parent company on US FDA and Health Canada regulations
• Conduct internal audits of QMS including product and production processes
• Prepare and conduct regulatory affairs training to personnel
• Prepare and report quality metrics
• Performs other duties, as assigned

Benefits

• MEC (Minimum Essential Coverage) plan encompassing Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services
• Glassdoor
• 3.5
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• Mayfield Heights, Ohio, USA
• http://www.nescoresource.com
• Late Stage
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• Michael McDonald
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Qualifications

• a highly talented and well-experienced Regulatory Affairs Specialist with FDA experience
• 3-5 years' experience in Regulatory Affairs, Quality Assurance or Quality Systems within a FDA regulated industry
• Working knowledge of GMP principles
• Working knowledge of 21 CFR 820, ISO 13485, CMDR, European Council Directive
• 4 Year College Degree or practical experience in Regulatory Affairs or Quality Assurance
• A highly talented and well-experienced Regulatory Affairs Specialist with FDA experience

Required skills

• 21 CFR 820, Canadian Medical Devices Regulations (CMDR), European Council Directive, FDA Regulations, ISO 13485, Manufacturing Practice (GMP), Quality Assurance, Quality Systems, Regulatory Affairs

Experience

• 3-5 years