About this opportunity
Senseonics, Incorporated lists this Principal/Sr Principal Regulatory Scientist opportunity in wichita, Kansas. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Summary:
We are seeking a Principal/Sr. Principal Regulatory Scientist who will be responsible for preparing, reviewing, and submitting documents for global product approvals. These documents include 510(k) notifications, Investigational Device Exemption applications, Premarket Approval applications, Technical Files, amendments, and appropriate follow-up responses to Regulatory Agencies.
Duties and Responsibilities:
Prepare submissions to gain approvals for clinical research and commercialization, such as: 510(k), IDE, PMA, Clinical Trial Submission (OUS), and CE-Mark Technical Files.
Develop, justify, and document sound regulatory strategies to support corporate goals.
Review and approve document change orders (DCOs), technical documents, test protocols and reports, as applicable.
Provide support to market-released products, as necessary.
Qualifications:
M.S. degree or higher in a Science, Engineering or related technical field of study
10 – 15 years of experience in a Regulated industry, preferably Medical Devices industry
Demonstrated success in management of regulatory submissions activities
Understanding of global regulations
Strong technical knowledge of medical products
Ability to effectively manage multiple projects
Excellent written and oral communication, technical writing and editing skills
Strong leadership and interpersonal skills
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.