Responsible to be a Member of the Regulatory team that ensures regulatory approvals are effectively obtained and compliance with regulations is maintained. The specialist may participate in product development teams. Author regulatory submissions and technical files. Organize regulatory information and tracks and controls submissions. This role can be 100% REMOTE.
Review and advise on labeling for compliance with regulatory filings. Review product changes for impact on regulatory filings worldwide. Research regulatory issues and provides guidance and advice to colleagues. Review product complaints to determine if the events are reportable to regulatory agencies.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Completes submissions for countries of varying complexity with guidance from the Regulatory team. This would include 510ks to international registrations.
- Provide regulatory guidance to assigned product development team to ensure the documents the team develops will meet the needs of the regulatory submissions.
- Timely compile materials for license renewals, updates, and registrations
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Review labeling and labels for compliance with regulatory requirements
- Review changes to existing products and SOPs to define the requirements for regulatory submissions
- Provide the regulatory reviews of customer complaints and define the regulatory reportability
- Maintain current knowledge of FDA and international regulation, guidance, and standards applicable to company products
- Actively participate in evaluation of regulatory compliance of document/ product/process /test methods changes
- Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management as required.
- Review of product complaints to determine if event is reportable.
- Works with other departments (QA, Clinical, Service, and Engineering) to insure complete and accurate information in file.
- Document’s decision to report or not report event.
- Prepares reports (MDRs, MDVs) for submittal.
- Provide trend reports on adverse events as needed.
- Embody and deliver the “Exceptional Everyday”
- BS or BA in engineering or scientific field.
- 1 – 2 years relevant experience within the regulatory discipline, 3 – 5 years without a degree.
- Excellent communication skills
- Ability to manage multiple priorities
- Requires creative, problem-solving ability and oral and written presentation skills
- Team oriented, the ability to work in small team environment is essential; must also be a self-starter with the ability to work independently.
- Good planning and organization skills are vital.
- Strong critical thinking and problem-solving skills
- Effective verbal and written communication skills are essential.
- Knowledge of US and international medical device regulatory requirements.
- Experience with electromechanical and/or software devices is a plus.
- Requires proficiency with standard software (Word, Excel, PowerPoint, etc.).
- The ability to meet deadlines and be detailed orientated is necessary.
Job Category: Quality Assurance
Job Location: Remote
Job Type: Full Time
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