Product Manager

Diasorin Molecular Llc   Cypress, CA   Full-time     Product Management
Posted on January 9, 2022
DiaSorin Molecular LLC, a developer, manufacturer and distributor of molecular diagnostic and immunoassay products seeks applicant for Product Manager at its location in Cypress, CA. Representative duties include managing the promotion, pricing and distribution channels for products to achieve financial and strategic goals, in compliance with applicable FDA, ISO, IVDD, and CMD/CAS regulations and requirements. Travel less than 5% to conferences or meetings. Requirements include a Bachelor's degree in Biotechnology or closely related field, plus 3 years' related experience in the point-of-care diagnostics product or medical device industries. Experience must include communication with key customer stakeholders, demonstrated sales growth in assigned products, execution of submissions to FDA for product approvals. Experience must also include product development leadership to include overseeing user interface development and submission of 510K's to FDA and obtaining IRB approvals. Experience must also include compilation of master records and design history files, validation and verification of diagnostic products in accordance with FDA regulations. Please submit resume and detailed cover letter addressing all requirements online at https://www.diasorin.com/en/open-vacancies