Regulatory Affairs Associate
Manufacturing · Remote / National

Our client in the biomedical device industry is looking for a Regulatory Affairs Associate to add to their remote United States team. You will be responsible for writing and submitting US 510(k), and EU regulatory filings with a willingness to learn other global regulatory requirements. You will also provide ongoing pre-market and post-market regulatory support as products emerge in new markets. To be successful in this role, you must have regulatory affairs experience in the manufacture and distribution of sterile, disposable medical devices. The ability to interpret regulations and guidance, and correctly apply them as appropriate in product development, is crucial. As global reach branches, the regulatory team will need to grow, so this role provides a clear path for upward career mobility. This is an excellent opportunity to join a growing company with an inviting team culture committed to the improvement of patient lives.