Reprise Biomedical is an early commercial stage biologics wound care company focused on bringing unique clinical solutions to the unmet needs of physicians. With our transformational Miro3D wound matrix on the market and new products in development we are ready to begin our growth with an internal regulatory affairs department.
We are seeking a knowledgeable, hands-on Sr. Regulatory Affairs Product Specialist with the ability to independently handle all aspects of Regulatory Affairs for a small but growing medical device company with class I and class II U.S. based products both on the market and in various stages of development.
We prefer candidates with a bachelor’s degree in a scientific discipline and a minimum of 4 years of technical experience in a regulatory capacity performing all aspects of regulatory affairs for the entire product life cycle including a track record of drafting, submitting, and defending successful 510(k) applications. Experience working with biologics or tissue-based products is also preferred.
In this role you will:
- Lead the regulatory strategies for new products by preparing, submitting, and defending 510(k) submissions to the FDA.
- Provide technical review of data and reports to be incorporated into regulatory submission to ensure scientific rigor, accuracy, and clarity of presentation.
- Ensure regulatory requirements are met so company products can be legally marketed.
- Represent RA on cross functional projects including product development, manufacturing process changes, and continuous improvement efforts.
- Evaluate changes to documents, products, processes, and test methods for regulatory compliance.
- Review product labeling to ensure claims are consistent with the cleared/approved intended use.
- Perform device surveillance to ensure adverse events or malfunctions are appropriately reported.
- Provide CAPA, audit and post market regulatory support.
This role will work full-time in our office in Plymouth, MN. We are interested in every qualified candidate who is eligible to work for any employer in the United States. However, we are unable to sponsor visas both currently and in the future.
