Assist in the preparation of regulatory submissions and filings, such as applications, amendments, supplements, annual reports, deficiency letter responses, Form 483 responses, warning letter responses, adverse experience reports, recall communications, license renewals, registrations, reports, correspondence, telecommunications, etc. Gather, assemble, and pre pare appropriate documents for submission.
Independently research regulatory issues and/or information as directed.
Independently track and follow-up on Regulatory commitments to assure commitments are completed and maintained.
Prepare documents, as directed, for internal use or submission to regulatory authorities.
Support regulatory filing processes in collaboration with a multi-disciplinary professional support staff
Independently monitor and improve tracking/control systems for regulatory documents
Other duties as assigned
Responsibility and Authority Affecting Quality
Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.
Identify and record potential problems relating to the product, process and Quality System.
Initiate, recommend or provide solutions through designated channels.
Record and/or report all instances of customer feedback on product.
Skills and abilities (required for the job)
Excellent communication skills
Excellent writing skills
Excellent skills in legal research
Strong organizational skills
Ability to handle multiple tasks simultaneously
A team player
Experience in medical device post market surveillance preferred
Education, experience and training (required for the job)
Bachelor’s degree or equivalent combination of education and experience
3 to 5 years of relevant experience, or equivalent
Work Station Area: Office
Special Factors in the Work Area: None
The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
The position requires the ability to communicate in person, telephonically and via email.
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