Salary: $82,000.00 – $108,000.00
Client is seeking a Senior Regulatory Affairs Specialist to joint their team.
This position is going to be a critical role for the team. They need a person who really understands compliance and has done some work on it. They need to have hands on work in a similar role and/or in a team that was working on similar tasks – FDA filings, European/ Asian filings, familiarity with the obligations we have as we do the leg work and filings. Even if they have worked under the supervision of a director/ manager/ etc. Does not have to have deep dive knowledge for Asia but wants to know that they can find them and know where to look. They have just started doing submissions for IVD’s. It would be great if they also understood genomics industry as well (this is going to be more complex than some of the simpler products on the market).
The IVD can include reagents and/ or other components that have to have approval.
BA in sciences or higher/ RAPS degree is good as well but the industry piece is going to be the most critical.
This person must have a strong level of attention to detail, good organizational skills, solid project / organizational skills.
As a Senior Regulatory Affairs Specialist, your job responsibilities will include, but not be limited to:
• Participate in new product design and development project teams as regulatory affairs representative. Ensure all regulatory requirements are met throughout the development process as per FDA QSR, ISO 13485, China FDA, Japan PMDA and Rest of the world regulations
• Review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. Author regulatory plan associated with the products.
• Actively participate in evaluation of regulatory compliance of document / product /
• process / test methods changes.
• Create and maintain product 510(k), EU technical, China FDA, Japan PMDA and country specific regulatory submission files
• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. Responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies.
• Organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings
• Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
• Compile materials for license renewals, updates and registrations. Responsible for timely registration of the facility and products.
• Review changes to existing products and SOPs to define the requirements for regulatory submissions
• Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
• Review labeling and labels for compliance with regulatory requirements
• Provide the regulatory reviews of customer complaints and define the regulatory reportability
• Maintain current knowledge of FDA QSR, ISO 13485, EU, China, Japan and other international regulation, guidance and standards applicable to company IVD and medical device products
• Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required. Supervise regulatory consultants
• Bachelors or Master’s degree in Biological Sciences and/or equivalent combination of relavent experience and education.
• 4+ years of regulatory work experience (similar industry preferred but not required)
• Working knowledge of Genomics, biological reagent, microarray, instruments, software and assay work flow
• Good knowledge of ISO 13485 and FDA QSR quality management system requirements and IVD products
• This is an advanced level hire.
• Up to 5% travel may be required for regulatory meetings and training
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