BAYER U.S. LLC – $158,226.00/Year

First Alternate Education and Experience A masters degree or foreign equivalent degree in Biomedical Engineering or a related field plus four 4 years of experience in a related position.br br Second Alternate Education and Experience A Ph.D. or foreign equivalent degree in Biomedical Engineering, or a related field plus two 2 years of experience in a related position.br br Must also have any experience with or knowledge of i interacting with Regulatory Affairs and crossfunctional partners to create Regulatory strategies in support of both new product development and life cycle engineering significant change submissions for MR modality Radiology products to countries within APAC, LATAM and EMEA, including technical documents, and dossiers needed to gain product clearance; ii global medical device regulations that are applicable to MR Radiology products, both electromechanical and sterile disposables; iii MR medical device Quality Systems and supporting Internal Audits; iv coordinating technical assessments for MR products in support of EU MDR certification for review by a notified body ; and v 21 CFR 820, EU MDR, EU MDD, ISO 14971, ISO 13485, ISO 10993, MDRs, Regulatory Statement of Conformity RSoC; vi MR Labeling and promotional material review to ensure compliance to global regulatory requirements; vii reviewing customer complaints for safety issues; nonconformances and CAPAs for effectiveness; viii preparing 510K submissions to the U.S. FDA; and ix regulatory registration requirements to support global submission dossiers for MR electromechanical, sterile disposable and software products.br br Experience can be concurrent.br br Note Since there is no experience required in H.6, the Kellogg Language is not required.