Himani Dureja’s Post

Contract Role || Regulatory Affairs Consultant III || Monroeville, PA || W2 Education: Bachelor's /Master's degree or equivalent. Significant leadership experience in role. Work independently on Regulatory duties, processes and roles outlined below: 1. Create and execute Regulatory Strategies and Plans for assigned medical devices in the US and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers. Participate and provide regulatory guidance to assigned medical device new product development and sustaining projects. 2. Primary responsibility for Regulatory submittals and assessments for the US, Canadian and EU markets. 3. Prepare and submit 510(k)'s and other product submissions according to FDA guidelines 4. Create and update European Technical File and Declaration of Conformity documents (MDD, R&TTE, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines 7. Support internal and external quality audits, as needed. Interested Please revert  Himani.Pureja@Modis.com