Regulatory Affairs Specialist

Understands and has working knowledge of FDA medical device regulations, European Medical Device Directives, and/or other global regulations. Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around product development goals. Prepares U.S. FDA submissions (e.g., 510(k), IDE, PMA) as required and per applicable SOPs. Initiates and updates technical files/dossiers/registrations as required and per applicable SOPs. Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards. Ensures adequate documentation of Bard Peripheral Vascular’s compliance to FDA, European and global regulations and standards. Ensures maintenance of the Regulatory Affairs files. Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Bard Peripheral Vascular’s notified body.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in 1329 US-6, Holdrege, NE 68949, USA is $48,000 to $64,000 per year, with the median salary being $56,000 per year. The salary range may vary depending on factors such as the specific job duties, level of education, experience, and the company offering the job.

The BD Life Sciences segment delivers innovative solutions from discovery to diagnosis, continually advancing science and clinical outcomes across infectious disease and cancer. Offerings include preanalytical solutions for sample management, immunology research solutions, including flow cytometry and multiomics tools, microbiology and molecular diagnostics, lab automation and informatics solutions, as well as differentiated reagents and assays.