Principal/Sr Principal Regulatory Scientist (United States)

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